The TrackWise Center of Excellence is looking for a highly skilled Computer Systems Validation (CSV) and Software Quality Assurance (SQA) analyst able to perform within the multicultural team supporting numerous GxP TrackWise processes.  We are seeking an expert in GxP computer validation, 21 CFR Part 11 and Annex 11 requirements, and possessing excellent interpersonal, communication and critical thinking skills.

Job Responsibilities:

• Provide estimates and forecasting for CSV and SQA project resource needs
• Assist in developing and approving computerized systems requirements and functional specifications
• Create GxP deliverables such as validation master plans, test plans, installation, operation and performance qualifications (IQ\OQ\PQ), test scripts, validation summary reports, risk control strategies and risk assessments for changes to validated systems
• Conduct system testing for emergency, and maintenance and enhancement releases
• Document and provide feedback to development teams on issues and bugs identified during testing
• Maintain accurate bug tracking and issues resolution logs
• Develop and execute manual and/or automated test documentation in accordance with approved processes and established standards, and in compliance with applicable regulatory expectations 
• Document test results and work with development teams to resolve test deviations; perform root cause analyses
• Develop new processes and process improvements
• Coordinate with cross-functional teams including Quality to ensure accuracy of all testing documentation
• Partner with development teams to support installation activities and configuration management
• Escalate issues and deviations as needed to management
• Provide subject-matter expertise on software quality assurance best practices, regulatory expectations and 21 CFR Part 11 and Annex 11 requirements
• Liaison with Quality to ensure compliance with corporate policies and procedures (SOPs)
• Oversee contract validation personnel
  
  

Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup?  What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs?

We do all of that at Genentech.  We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment.  We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives.

We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms.  We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit.

You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude.

Key Responsibilities:

• Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions
• Provide deep technical expertise over a broad set of current technologies and platforms and mentor other team members in these technologies
• Deploy new software enhancements, troubleshoot production systems, contribute to root cause analyses and provide excellent customer service to a 24x7 manufacturing operation
• Work with a variety of in-house developed, commercial off-the-shelf (COTS) and open source software

As a Principal Staffing Consultant, you will play a lead role in managing the recruiting and hiring programs for our Product Development Staffing 

Main Deliverables:

1. Play a lead recruiting role for approximately 100 positions annually, with an average requisition load of 30-40.
2. Play a lead role in key Product Development  wide staffing initiatives, including those supporting our diversity and hiring best practices programs
3. Partner actively with HR Management to drive internal talent development and succession planning programs
4. Provide original thinking to staffing challenges and execute on ideas for improving patterns of work

Main Accountabilities:

• Deliver Recruiting Results
• Recruit with Insight and Strategy
• Innovate and Expand Possibilities
• Value Collaborations, Communication, and Teamwork
• Execute on Tactics, Tools, and Technology

Full Responsibilities:

• Managing expectations of hiring managers and candidates, identifying and resolving issues
• Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
• Demonstrate thorough understanding and adherence and enforcement of internal staffing process as well as contribute to the development of staffing process improvements
• Ensures recruiting solutions are consistent with Corporate Staffing goals and objectives
• Partner with Diversity and sourcing counterpart to develop and implement sourcing plans and strategies for your client groups while ensuring that the elements of diversity and organizational fit are included in the recruiting and hiring process
• Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
• Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
• Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
• Build and maintain cross-functional relationships across HR and Staffing
• Utilize, update and maintain applicant tracking system and CRM
• May provide staffing reports and metrics
• Present information on results and metrics at different levels (i.e. to employees, peers and senior level HR and client groups)
• Act as point person for clients in providing staffing reports and metrics
• May Lead and or participate in HR related projects or enterprise wide initiatives.
• Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
• Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
• Partner with Diversity and HRDs to develop and implement a recruiting strategy that ensures our candidate pipelines are diverse
• Conduct interviews using in depth behavioral and skills assessment techniques
• Educate hiring managers on legal implications in hiring
• Adjust the strategy and align it with the changing needs of the business
• Ensure your compliance with EEOC/OFCCP regulations
• Act as project manager for client focused staffing projects (not just req focused)
• May partner with finance in determining headcount for client group, as well as manage the reconciliation of budgeted headcount vs. actual headcount
• Work with Staffing Manager on recommendations for the EC Group recruitment/relocation budget
• Oversee relocation/recruiting budget for individual client group at the officer level
• Manage multiple relationships, both internally and externally
• Attend professional conferences and networking events
• Responsibility for Conference/Event management related to external recruiting, partner with Corp Staffing in strategic direction of event, and determine ROI for event participation

The Senior/Principal Health Economist is part of the broader Oncology Medical Unit organization and provides health economics and outcomes research, modeling, reporting, and other relevant analyses, within applicable legal and regulatory guidelines, which can be used to quantify the value of Genentech products in economic or societal terms. 

The Senior/Principal Health Economist will work with multiple products and indications within the Oncology portfolio and will support cross-functional Genentech and Roche teams by recommending, developing/conducting and advising on HEOR research and modeling strategies, and by developing medical and payer value propositions, portions of product dossiers, and other scientifically-based communications. 

This team supports strategic decision-making for late-stage development and across the product lifecycle. The Senior/Principal Health Economist helps set Genentech HEOR strategies, direction, objectives, and plans for innovative, effective and efficient execution. 

The Senior/Principal Health Economist will be fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. As a manager and coach of others, the AD/PHE is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, s/he leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. The Senior/Principal Health Economist monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. ¿

Responsibilities:

Incumbents are generally expected to:

• Functional lead for HEOR activities for the molecules and indications assigned, including participation in design and conduct of studies as needed

• Set and manage to outside spend budgets for multiple projects and products, including assuring that direct reports meet budget commitments and develop financial management skills

• Manage one or more health economists or other HEOR staff, with less than half of his/her time devoted to management

• Including hiring, development and ensuring technical excellence

• Directly engaged in designing, developing and conducting HEOR studies with strategic impact for the molecules for which she/he is responsible

• Maintain strong, positive relationships with senior internal stakeholders across Genentech and Roche 

• Lead development of the vision, strategic and tactical plans, resource and budget plans, for the products and indications under his/her responsibility.  Includes establishing annual and longer-range plans, goals and objectives, and effectively aligning these with Genentech and Roche cross-functional research, development and commercial strategies and objectives.

• Lead and manage execution to ensure work is completed on-time, on-target and within-budget, with the highest levels of accuracy and relevance, and in consistent compliance with legal and regulatory guidelines, Genentech and Roche policies & procedures:

• Working collaboratively, effectively and efficiently with all internal and external customers, partners, stakeholders and influencers

• Develop and cultivate relationships with key KOLs (Key Opinion Leaders) and other thought leaders, to support HEOR strategies, plans and objectives and provide strategic, critical influence for Genentech's product pipeline and portfolio

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Utilize only approved resources and messages to meet goals and targets

This position may be filled at the Sr. Business Systems Analyst or Principal Business Systems Analyst level.
 
The Sr./Principal Business Systems Analyst position is dedicated to business process analyses, design and optimization to enable the routine delivery of exceptional performance. This position sits within the MCCO Data Governance and Management (DG&M) department, which is charged with assisting the Strategic Pricing & Contract Management (SPCM) organization to achieve its goals and objectives.
 
This individual will be responsible for leading cross-functional process improvement projects, representing the department as the change agent, partnering with customers, leading internal efforts within the team, communicating and coordinating with key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in industry best practices, process improvement methodologies, and will be accountable for following/improving upon the methodology in alignment with Genentech values and behaviors.
 
This position will lead cross-functional project teams to:

•  Implement practical and sustainable business processes
•  Maintain department scorecards
•  Update and prioritize multiple project portfolios
•  Deliver project goals on budget and on schedule
•  Analyze business, process and systems performance, and identify improvement opportunities
•  Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses
•  Make recommendations to Senior Management based on business case and analyses
•  Lead decision making support and make recommendations regarding best options
•  Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution
•  Develop and use project plans to coordinate participants and track and report progress
•  Leverage industry research and analysis
•  Serve as advocate, mentor & role model for integrating best practices into the organization
•  Ensure improvement methodology and tools are utilized effectively to maximize benefits
•  Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical ...

Main Purpose of the Position:    

·         Support the development, implementation and management of the overall environmental control program in SSF Drug Substance and Drug Product Manufacturing following, cGMP regulations, Genentech and Regulatory requirements.

·         Provide Quality oversight from and critically evaluate EM issues, discrepancies, Media Fill data, airflow evaluations, and assess facility/process changes.  

·         Develop solutions to complex issues and Quality initiatives with inter-organizational impact.

·         Perform tasks and work to achieve company goals and organizational objectives.

Technical Duties/Responsibilities:

·         Provide oversight of the Environmental Monitoring (EM) program ensuring consistency with company/regulatory policies and procedures.

·         Present and provide rationale of EM program during periodic audits and regulatory inspections.

·         Provide input in the preparation of regulatory submissions.

·         Provide input into investigations involving suspect equipment, utility or facility failures resulting from EM activities.

·         Provide Quality oversight throughout the Drug Substance and Drug Product Manufacturing areas. 

·         Provide technical assessment and approval for changes to the EM program.

·         Collaborate with departments to ensure that EM activities are executed efficiently and effectively.

·         Provide oversight to the Media Fill program and create Media Fill protocols and summary reports.

·         Execute Airflow Visualization studies and create summary reports.  

·         Provide guidelines for area/system Shutdown Authorization Request (SAR) activities.

·         Ensure proper policies and procedures are established to guide EM efforts.

·         Ensure department representation on relevant project teams.

·         Identify, design, and implement environmental monitoring process improvements.

·         Communicate group performance against established metrics to Quality Management.

Main Purpose of the Position:
• Supervise and develop staff completing Change Control activities and drive resolution of complex change control issues following cGMP regulations and Genentech standards. 
• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee lifecycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities.
• Determine and communicate objectives and accountabilities for direct reports.
• Regularly review staff progress in meeting objectives.
• Recommend improvements to Quality operational policies, plans and procedures.
• Ensure activities are completed on time and issues resolved within budget.
• Make recommendations to department budget and staffing needs.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Oversee the impact assessment of proposed changes and ensure appropriate approvers are selected for changes.
• Supervise change control activities for validated systems, qualified equipment, and controlled documents.
• Participate in cross-site change management forums. 
• Supervise staff conducting change control activities for quality and business systems support in GMP areas. 
• Participate in business process improvement programs and process redesign initiatives.
• Promote and provide guidance in Good Documentation Practices. 
• Supervise lot release restrictions imposed by system, process, method and equipment changes.
• Ensure the completion of required actions prior to lifting lot release restrictions. 
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Act as a resource for Change Control knowledge management within Quality Operations and across site Quality departments.  
• Collaborate with site Quality and Production units in the administration, access, and communication of the Change Control system.
• Participate in change control automation and business process improvement initiatives. 
• Supervise Record Management, Retention and Repository program activities and processes.
• Collaborate with Quality and Production departments to maintain GMP records.
• Ensure backup and disaster recovery system activities are implemented and maintained for critical GMP records. 
• Ensure data integrity and recoverability of electronic GMP records according to Genentech policy.

Job Summary

The Senior Statistical Programmer Analyst (Senior SPA) works with cross-functional teams in Medical Affairs and external vendors and leads the activities in the planning, design, development, implementation and management of software and data to fulfill reports and summarized information required in support of post-marketing clinical trials, registration studies, investigations and assessments of claims databases, including health economics and outcomes research projects for Genentech and Roche products. The Senior SPA also supports internal and external requests for input into relevant documentation and materials, such as manuscripts, conference posters and presentations.

Job Responsibilities:

• The Senior SPA provides expert guidance and direction regarding statistical programming design to support timely, targeted and accurate reporting and outcomes from assigned medical affairs projects.
• He/she works closely and collaboratively with internal cross-functional partners to ensure thorough representation and alignment of cross-functional programming, data and reporting needs and objectives.
• He/she expertly manages external vendor partners supporting software developments, enhancements, maintenance and reporting to ensure consistently on-time, on-target, and accurate deliverables.
• He/she provides timely, accurate and adequate responses and inputs to/into internal and external questions, medical affairs documentation and materials.
• He/she competently and independently develops, manages, and maintains software analysis data and reporting deliverables for assigned Genentech and Roche products.
• The Senior SPA provides technical solutions to a wider range of problems with higher level of complexity, independently determines and develops approach to solutions, and recommends technical and process solutions that can be used or developed to increase efficiency of project work.
• The Senior SPA also effectively represents the department, as assigned, on cross-functional projects or work teams, and also helps on-board new team members, as appropriate, and completes special projects as assigned.

• Focuses on process optimization and continuous improvement of existing Identity & Access Management processes and tools
• Follows established processes and standards in the execution of daily duties and job function

• Develops the Identity and Access Management services
• Promotes the Identity and Access Management services with all customers
• Supports the integration process of new or updated components by following established standards and providing the expected deliverables for handing over the service to operational teams and customers.

• Supports the integration of registration processes within the company’s identity management solution with focus on improving the operational environment, processes and procedures including data migration activities
• Follows appropriate SOPs and instructions required for the integration of registration services

• Manages the configuration and master data by assessing and specifying the possible need of data quality improvements
• Applies change management processes while managing the Identity & Access Management process integration
• Support the integration of business processes and applications by leveraging the Identity and Access Management infrastructure, tools and directories and following project management best practice.

• Manages the analysis, design and handover of access registration processes to the operational teams
• Ensures proper documentation and training material regarding registration processes is in place and kept up-to-date
• Manages the identity and access management processes to meet OLAs/SLAs by adhering to regulatory and qualitative requirements
• Increase process efficiency and cost effectiveness while providing identity and access management services
• Manage the integration of registration processes with focus on improving the operational environment, processes and procedures
• Manages and maintains the registration process portfolio
• Monitors and verifies the effectiveness of registration processes through established KPI and trend analysis
• Contributes to audit processes
• Based on business needs, identifies and proposes innovative, integrated, economically viable solutions
• Integrate identity and access management processes by meeting SLA requirements
• Supports that all solutions, documentation and procedures are implemented and maintained in a fully qualified and current state as applicable
• Registration processes are clearly communicated and trained
• Continuously strives for increase the skill level and expertise in the corresponding area
• Keeps abreast of business needs by maintaining close relationship to service management and other support services teams.
• Ensures compliance to Roche and Informatics Standards for technology, monitoring and support tools, SOPs and policies
• Ensures that documentation is current and accurate, SOP’s are understood and adhered to and platforms operate in highly secure and qualified environments in compliance with Audit, Regulatory and Validation requirements
• Ensures SLA requirements are understood and the required processes are implemented and managed to support compliance
• Provides shared platform support services as agreed (SLA or other) with the SM functions and other service consumers
• Provides input to support service levels and costs
• Fosters a working environment that encourages team members to fully contribute to achieve Roche’s goals
• Actively provides feedback to customer and team seeking for process improvements and efficiency gains
• manages the different integration projects within the portfolio to integrate new/existing IM applications into the service
• ensure standardization and globalization of application registration services by improving the operational environment, processes and procedures
• interface with the corresponding Engineering team if new features/interfaces are required
• ensure proper testing of application registration integration
• handover of new productive application registration processes to the operational team(s)
• create metrics/key performance indicators and develop/apply ...

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

Accountable for end-to-end infrastructure and ensure thecomplete integration of the solutions into the operational landscape. SupportSolution owner with lifecycle management and Components.

This includes installation and upgrade throughmaintenance and operations to decommissioning.

1.2 PrimaryResponsibilities

• Provides technical Subject Matter Expertise input into solution design, optimization, change requests and problem resolution
• Participates in implementation of new projects and in changes of existing solutions and actively execute project related tasks and activities.
• Coordinates and manage installations, upgrades, changes and software integration including test design, execution and support
• Ensures the integrity of solutions and qualified state during their lifetime
• Coordinates and supports security patching and upgrades with the Solution Owners
• Ensures compliance with security SOPs/policies, and that adequate access rights are given to trained staff.
• Coordinates incident management activities with Solution Owners and the AE&O component Managers until final resolution and supervise re-active problem management process

• Identifies and analyzes potential areas for improvement of the solution (pro-active problem management), and Delivers continuous improvement of the solutions assigned.

• Represents the Delivery Organization into AE&O so that the business is represented in technology decisions, planning and participation.
• Ensures solution design and integration of the AE&O skill sets required to support the new solution
• Ensures re-use of existing AE&O solutions and components wherever possible to minimize the development of new solutions
• Ensures all new solutions are designed and developed in a cost efficient manner, delivering the appropriate level of service quality

• Ensures communication of AE&O initiatives, policies and important activities to appropriate Delivery Organization.

Act as the main point of contact between Solution Owners, Project Managers and the Operations Support team in the release or implementation of new services, applications or products into production. Ensures smooth transition of new Operational Services and provides implementation support for the Regions

• Ensures tools, processes and procedures are in place to enable the Regions to support new services, applications and products
• Coordinates with the AE&O Support Processes & Continuous Improvement team and the Regional Account Managers on the release and design of new services, applications and products into production 
• Develops methods to track and monitor the Service Health and provide initial reporting
• Acts as the main point of reference and is consulted in Operational AE&O IT projects that impact the tools, processes and technologies used in the Operational Teams in the support of AE&O provided services
• Develops Training material for new Services in collaboration with the solution owner and coordinates the Trainings with the Regional Account Managers
• Assists the Site Implementation Team during the integration of new sites or acquisitions to ensure Processes, Training and Regional/Local Support is in place.   
• Coordinates with the Support Processes & Continuous Improvement Team, the AE&O operational Teams and the Regional Account Managers to ensure tool and Process availability for a upgrade to an existing service, new service release or implementation 
• Ensures and coordinates knowledge base updates with any required information to support a release or implementation
• Ensures Training material availability on new processes and procedures and coordinates Trainings in cooperation with the Regional Account Managers
• Reviews project plans with the Solution Owner or Project Manager for transition planning and provide feedback to ensure a smooth release or implementation.
• Provides reports and monitoring on the impact of releases and implementations on the AE&O operational Teams and the Regional and Local support teams and drives improvements until normal operations are achieved
• 
  
• Works with Solution Owners and Project Managers to ensure that requirements of the Operational Teams and the Regional/Local Support teams are represented and understood
• Ensures efficient processes for Operational and Supporting teams and establish an aligned incident escalation chain to reduce escalations. 
• Push automation opportunities for request and change management, reduce escalation of incidents by enforcing Knowledge management usage and validation of KM data.
• Establish early reporting and Service Health metrics with trending information on incidents, requests and changes. 

• Plan and execute stress, performance and functional Test on applications and systems using automation and manual Testing. 
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (HP Suite, Selenium, Segue, etc). 
• Lead the development of SQA Test Plans, Specifications and Project Scheduling. 
• Collaborate with other SQA Leads in the development of  QA/QCProcedures, Test Scripts, and SQA lab standards and tools requirements. 
• Identify opportunities for process improvements that streamline development activities while minimizing risk.
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage onsite and offshore testers

The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

• Serve as the Site Manager overseeing clinical contract manufacturing organizations (CMOs) or clinical distribution organizations (CDOs) that are needed to meet clinical supply requirements in supporting clinical labeling and packaging. 
• Lead and collaborate with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives in addition to performance goals for the contract manufacturing or business partnerships.
• Manage the operational activities of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. 
• Develop solutions to complex issues with inter-organizational impact.
• Prepare Requests for Proposals (RFPs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
• Support development and continuous improvement of the supply relationship with IMP CMOs/partners.
• Position may be filled as an E3 or E4 depending on candidate’s experience and qualifications.

Responsibilities:

• Responsible for overseeing execution activities of clinical contracting manufacturing organizations (CMOs) to support labeling and packaging outsourcing activities for clinical studies. Scope is from release of DP at the Filling site through release of Final Packaged Goods at the label/pack site; scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary DP materials and FG components are available for execution.
• Ensure reliable supplies of Final Packaged Drug Product (including Other Study Drugs as required) to our customers and our patients, while meeting acceptable quality standards and Genentech’s financial and development goals.  Proactively intercede if goals and timelines are jeopardized.
• Coordinate operational activities with internal cross-functional teams (Clinical Planning, External Quality, Distribution) to ensure on time release of packaged clinical product.
• Participate on cross-functional teams in evaluating and selecting CMOs for a particular project as requested. 
• Prepare a Statement of Work (SOW) as required.  The preparation of an SOW can include negotiation of project fees, negotiation of milestones, defining responsibilities between Genentech and the CMO and keeping Legal, Procurement and other groups up to date on SOW progress.
• Provide input to the internal CMO/partner SPOC ensuring that the overall relationship between Genentech and the CMO/partner is healthy. 
• Develop, maintain and drive key health metrics between GNE and the CMO to ensure effective and continuous improvement of business performance and relationship.
• Participate in Master Service Agreement creation and maintenance as requested so that it accurately reflects the existing business relationship.
• Proactively identify risks.  Create strategies to avoid or minimize their impact.  Manage the execution of risk mitigation plans. Participate in and contribute to drug development telecons in an effort to proactively intercede if a relationship issue jeopardizes the project.
• Create purchase orders.  Review and approve invoices for GNE payment and coordinate on-time CMO payments.  Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis.
• Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
• Report as needed on performance and operations at Operations Review.
• Support External QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• International and domestic travel as required. 

Requirements:

• Collaborative Leadership - Ability to strongly influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.
• Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly.
• Communication - Ability to communicate effectively at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity.
• Planning/Organization - Excel...

Main Purpose of the Position

Description:  This Site Manager will manage the Production oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMOs) located in Greenville, North Carolina.  This person will be a team leader on a CMO governance team to support right to operate and supply of critical biologic products, including a product launch.  

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as a point of contact for the contract manufacturing relationship at the Joint Management levels.

* Lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Participate in and/or Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including potential to serve as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management. Lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche/Genentech Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments suppor...