Senior Director, Contracts Process and Operations 

Location:  San Francisco

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable  as the global contracts business process owner to ensure optimal GPP value delivery to our business partners.   

* This leader will be leading an organization that is bringing together all GPP contracts teams into one function to leverage best practices and align with the GPP Go Simple project to streamline contracting processes within GPP.  

* This leader has strategic accountability for activities associated with development and execution of contract agreements for all GPP customer groups globally (Product Development, Research, Technical Operations, Global Product Strategy, US Commercial and US Site Services) 

* This leader is the primary liaison with senior leaders in various GPP client groups and US/EU legal organizations and must be able to effectively influence senior leaders

* Accountable for appropriately managing legal and compliance risk on behalf of Roche in the execution of the contractual process including negotiations of terms and conditions. 

* This leader is accountable for connecting the Contracts process to solutions (IT) and service delivery.

Key Relationships

• Internal: Provides guidance and mentoring to Contracts staff members in contract development and administration and working effectively with Genentech user community and vendors

• Business Partners 

• External: Seeks out industry benchmarks

• IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages  6 direct reports and manage a team over 110 employees and contractors.

* Responsible for developing and implementing contract processes and managing a group of professional contract staff globally representing all GPP functions.

*  Ensures that a wide variety of company contracts are negotiated and processed to meet the needs of multiple client groups.

* Manages the contract process from initial request to contract execution, focuses on agreements with complex legal and business risk.

* Actively manages the GPP Contract process and support the connection to the overall Procurement Processes of Category Management, Contracting, Request to Pay and Master Data processes. 

* Ensures all policies that govern the conduct of contracting activities are adhered to in accordance with all legal policies globally

* Works with Roche/Genentech user community to ensure there is a complete understanding of contract requirements.

* Works with direct reports, other team members, and various internal business partners to review contract service levels and performance.

* Participates in process improvement or other projects that enhance and streamline contracting processes, systems, tools and other resources; collaborates legal departments to improve contract templates and processes.

* Provides direction and training to teams regarding good business procedures and contract business terms; shares best practices and feedback on contract and budget matters to Contracts staff and  GPP teams.

* Identifies and manages areas of risk and compliance both in the establishment of contracts and in the operation of the contracts and the relationship with the outside vendor.

...

Category Lifecycle Process Leader, Director of Procurement

Location:  San Francisco or Basel

Purpose

* This leadership role is responsible for leading a team in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and is accountable for design and delivery of the global category management process. 

* This leader has strategic accountability for the overall category management process for GPP, and must work with SRO leaders to ensure the process connects to the Source to Pay Process. 

* Key accountabilities include creation of a GPP category management tool kit and sourcing, supplier relationship management and governance processes.

* This leader will be responsible for creating and implementing an overall outsourcing process, strategic framework and governance management, which will require engagement with GPPLT and key business leaders. 

* This leader will be responsible for creating and implementing the Global eSourcing Program to establish eSourcing as way of working across GPP. 

* Drives sustainable savings and eSourcing process automation across affiliates, sites & GPP functions through partnership and collaboration.

 

Key Relationships

* GPPLT, and functional teams

* GPP business process owners

* Affiliate Procurement Leaders

* Global/Regional/Affiliate Finance Leaders

* IT and the S2P Steering Committee

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 4-5 direct reports with total team of 10-15 employees and contractors .  Expand to 6 direct reports as Outsourcing Strategy and governance is established.

* Ensures the application of the GPP Category Management process is robust and established as a way of working through the Global Pharma Procurement functions. 

* Establishes and manages the Outsourcing process and strategy governance.

* Manages the connection through the coordination of the overall Procurement Processes of Category Lifecycle including Category Management, Contracting, Request to Pay and Master Data processes.   

* Manages the global category management process ensuring toolkit application and practice for both indirect and direct materials processes.  

* Manages process content and training materials for the category management and eSourcing processes.

* Establish and governs the Supplier relationship management and governance processes for GPP categories.

* Owner of the eSourcing Process:  Including improvements, system (IT Solution), Delivery of support and project portfolio.

* Sets up the eSourcing regional support model to support end to end eSourcing processes.

* Drives the adoption of eSourcing tool and processes globally.  

* Raises usage of eSourcing to increase effectiveness (deeper value) and efficiency (faster cycle time) through the use of eSourcing.

* Establishes and monitor global eSourcing targets in conjunction with savings targets.

* Identify eSourcing opportunities in conjunction with the GPP Categories.

* Manages sourcing project content and strategy including: project and bidding strategy, spend segmentation, recommendations for savings implementation, tender development (RFI, RFP, RFQ, auction formats) and managing multiple site project teams.

...

Director of Portfolio, Project & Process Excellence 

Location:  San Francisco, CA OR Basel, Switzerland

Purpose

* This leadership role is responsible for leading a team of leaders in the newly defined Global Pharma Procurement Strategy, Realization and Operations organization (GPP SRO) and has full accountability for driving global prioritization of our GPP portfolio and ensures the effective management of our transformation projects through excellence in project management and efficient processes.

* This leader is responsible for connecting together one GPP project portfolio that includes all GPP projects and ongoing resource management.

* Accountable for the Lean Six Sigma infrastructure by building short and long-term capabilities within GPP to meet the vision of becoming the best procurement team in our industry. 

* Partners closely with stakeholders and customers to collaborate, influence and execute on project and  Business Process Excellence across the entire organization.

Key Relationships

* GPPLT – final portfolio decision maker

* GPP Functional Leaders – functional portfolios feed into GPP portfolio; support BPE projects

* GPP Operations - Support the S2P Business process owners through continuous improvement

* Provide BPE expertise to business partners to support improvement to their processes

Key Responsibilities

* Reports to the Head of GPP Strategy Realization and Operations.

* Manages 5 direct reports, with a team of 15-20 employees and contractors.

* Oversight of the GPP Portfolio, Business Process Excellence, Project Management function and dedicated Project Communications support.

* Portfolio:  Prioritizes portfolio projects for GPP globally including resourcing and solution management.  

* Identify and prioritize strategic and operational initiatives to improve GPP’s performance along financial (savings), customer, process and people dimensions. 

* Prioritize the overall GPP IT Solution management and roadmap including maintenance and enhancements.

* Project: Develops a consistent stage gate review process to ensure all projects are set for realization of their intent and sponsorship.

* BPE and Project Support:  Provides vision and guidance to effectively support business process excellence – through achievement, sustainment and ongoing realization of business process management.  Ensure a robust infrastructure to support effective, efficient, innovative and agile operations. 

* Ensures projects achieves its intended realization.  Support overall change execution through the BPE tool kit.

* Builds BPE/OE capabilities and mindset within the network to empower others to make improvements on their own. Train others in the continuous improvement tools and techniques found in the BPE/OE toolkit.

* Communications:  Ensures GPP project and portfolio communications are aligned and connected to the overall GPP communication strategy. 

 

...

The Regulatory Advisor will be responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of Roche applications. The Roche Pharma Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with Roche Scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of Roche products developed using novel and efficient process development strategies. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.

 

The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support both US ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.

The Regulatory Advisor must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. Have a proven ability to work well under pressure.  The incumbent will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.

...

Position Overview/Job Responsibilities

Genentech Government Affairs’ Public Policy and Reimbursement team is seeking a qualified policy manager/senior policy manager candidate to monitor and analyze numerous public payer activities and trends, including coverage, coding, and payment policies at the national level for both Medicare and Medicaid.

Specifically, the policy manager/senior policy manager will help recognize, assess, and communicate key policy issues that may impact Genentech and the biotechnology industry in both the short- and long-term to key internal and external stakeholders. He or she will focus on the impact of public sector trends and initiatives on Genentech with respect to patient access, reimbursement, and customer satisfaction. He or she will translate policy developments into meaningful guidance and strategic advice and will represent the Public Policy team at internal and external meetings. He or she also will be responsible for managing projects effectively and efficiently, and will be required to take initiative to identify key issues and help organize and assist the efforts of other team members as appropriate.

...

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
  
  

...

Market Analysis & Strategy (MA&S) participates in commercial planning efforts by providing objective, in-depth information about Genentech's current and future markets, product performance, customers and competitors. Market Analysis & Strategy teams identify critical business issues and opportunities for growth; collaborating with various Genentech cross-functional teams to embed an external market point-of-view into the strategic direction of Genentech. Patient Insights is part of Market Planning and this group is charged with providing Genentech executives, management and cross-functional teams with highly current, relevant, and holistic market research, analysis, insights and recommendations regarding patient trends, dynamics and economic drivers that potentially impact Genentech's current and future business. Through their work, Patient Insights provides internal business partners and stakeholders with critical patient information and insights that help shape and form the best cross-portfolio business and operational strategies. Market Planning Managers/Senior Market Planning Managers in Patient Insights act as subject matter experts in patient insights and support the overall patient strategy for assigned Genentech franchises and brands with the goal to improve patient outcomes. Market Planning Managers/Senior Market Planning Managers in Patient Insights may also have people management responsibilities for one or more direct reports.

Example Duties and Responsibilities:

• Acts as lead contact for patient insights projects and ongoing consulting regarding the assigned franchises and brands
• Provides an objective commercial viewpoint, based on an in-depth understanding and analysis of patient dynamics and trends as these relate to the assigned franchises and brands: 

• Proactively and continuously monitors the external landscape, as it relates to assigned franchises/brands and existing or potential patient populations. Identifies, assesses and communicates patient trends (e.g., access, reimbursement, personalized healthcare needs, etc.)
• Acts as a thought partner and consultant to all relevant teams, functions and stakeholders
• Works closely with team members in Market Planning, other groups in Market Analysis & Strategy, Franchise Marketing, Patient Marketing, eMarketing and others to identify and plan for patient and related research programs and studies. Identifies, and/or participates in the identification of, critical opportunities for growth, and helps to ensure key patient insights are embedded in the strategic direction of Genentech's current and future businesses
• Participates in the identification of strategic issues or questions to be answered by research projects and/or through leverage of existing analyses and information.  Helps shape and structure patient and related market research programs and studies.  Participates in the definition of questions and required data. Works with his/her manager to identify themes across projects and information sources
• Performs regular and ad hoc patient and related market research, analysis and scenario modeling using primary research from commissioned studies and/or secondary research and analytics. Regular analysis may include patient segmentation, market share analysis and assessment, etc. Employs various analytical methodologies and techniques; and demonstrates understanding of potential and/or limitations of data sources and analytical methodologies. Develops a "command" of data and information sources and a sensitivity to biases.  Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Synthesizes data and identifies implications of patient and related influences relevant to Genentech's current and future business. (Where applicable, performs "meta-analyses" across projects and information sources where similar themes or opportunities may exist.) Draws substantive conclusions from results; identifying implications, challenges or other opportunities, and delineating clear next steps
• Provides internal business partners and stakeholders with a cumulative set of recommendations on patient strategies, plans and tactics (includes risk assessment and mitigation, new business opportunities, line extensions and the like)

• Provides strategic and operational patient insights and recommendations to support various Genentech business planning processes, e.g. long-range Business Plans, 3-year brand and 1-year tactical plans
• Acts as an industry expert on patient research and the general patient landscape, providing ongoing in-depth information and insights to internal partners and stakeholders
• Regularly communicates key patient and related market information to various teams and individuals throughout Genentech
• Complies with all laws, regulation...

System Specialist, gRED Desk-side Support

• The gRED Desk-Side Support Specialist supports multiple computing platforms such as Mac, Windows, Linux, and iOS in laboratory and desktop computing environments. 

• The successful candidate will also apply networking concepts, printer troubleshooting, hardware and software troubleshooting knowledge and data backup technology in day-to-day operations. 

• While working in a highly team-oriented environment, the gRED DSS Specialist will work to achieve defined metrics within the incident management and request fulfillment processes and also be a technical resource to junior team members. 

• The successful candidate would also have the potential to lead team efforts. 

...

The Jr. Programmer Analyst position will be responsible for providing production support for one or more Managed Care and Customer Operations (MCCO) business application solutions (such as the Contract Administration & Reporting System, Government Price Reporting, Validata, eWorkflow, and Channel & Inventory Management systems).

 

Duties:

• Provides operational support for Managed Care and Customer Operations business applications, including ticket monitoring, troubleshooting, and deployments
• Diagnoses and resolves user-reported issues within established Service Level Agreement timeframes
• Assists other Programmer Analysts with projects and maintenance & enhancement (M&E) releases as needed
• Consults business users to identify current operating procedures and deliver against business and system objectives
• Monitors and troubleshoot application performance issues
• Maintains system support documentation 
• Drives to complete assigned tasks and demonstrates accountability by contributing to the completion of milestones associated with specific projects.
• Acts as an effective team participant and collaborates on team direction and decisions
• Performs other duties as assigned

 

...

Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale.  Collaborate across multiple functional areas such as formulation development, manufacturing and validation.  Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus:  storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and vaporized hydrogen peroxide. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience....

There is an opportunity in the Technical Regulatory organization at Genentech at the Product Manager level.  This position requires use of regulatory and technical knowledge to develop, execute and oversee regulatory initiatives and strategies.  This individual will work with cross-functional project teams to develop regulatory strategy and ensure the success of regulatory filings through submission of high quality documents supporting the company’s development product portfolio.  Responsibilities will include accountability for IND, IMPD, and BLA/NDA/MAA applications as well as informational and pre-submission meetings with global health authorities, partners, and industry experts.  Additional responsibilities include leading departmental business process initiatives, and proactive communication with Regulatory and cross-function personnel and partners.  Candidates with a combination of broad technical, process and product development, and CMC regulatory experience are desired.

...

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech's Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and/or pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development.

All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.

For this particular position, a strong background in cancer immunotherapy or the biology of the tumor microenvironment, evidenced by peer reviewed publications in top tier journals, would be an important asset. The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

...

 The QC Pharmaceutical Specialist will be a member of the Method Transfer, External QC, and Method Monitoring group, which is part of ROCHE/GENENTECH’s Global Method Management and Technology (Global MMTech), the department responsible for the life cycle management of all commercial methods and control systems and innovation within Commercial Biologics Quality.
Method Transfer, External QC, and Method Monitoring is responsible for all aspects of assay transfer, QC support of CMOs and partners, and method monitoring activities across ROCHE/GENENTECH’s entire commercial network, including CMOs and partners. The successful candidate will provide QC oversight of Contract Manufacturing Organizations (CMOs) who manufacture and test commercial ROCHE products.

Job Responsibilities:
The successful candidate will be responsible for managing all QC aspects at our CMOs on a global basis as the single point of contact representing ROCHE/GENENTECH. The scope of this role includes all US based CMOs that manufacture and test Commercial Small Molecule Pharmaceutical Products. Responsibilities include, but are not limited to, the following key aspects: Qualify CMO for QC testing and data review; ensure appropriate adherence to cGMP requirements at CMO; work with appropriate subject matter experts to provide support to CMO in QC related investigations and analytical method issues; participate in laboratory audits and inspections; participate on Quality Review Boards as needed; manage change control for all CMO analytical methods and laboratory impacting activities; review and approve documents; manage critical reagents/reference standard supplies for CMOs; support preparation of Annual Product Quality Reports.

...

Solution Architect – Regulatory

 

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

 

The Position

 

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

...

Senior Finance Manager - Commercial Finance

The Senior Finance Manager is responsible for providing financial management and value-based business decision support to the Nutropin and Pulmozyme Franchises within the Genentech Commercial organization. This position reports to the Director, IMPACT Decision Support within Commercial Finance, and could be a Finance Manager depending on the candidate’s background and experience.

 

RESPONSIBILITIES

• Act as a business partner who adds value by understanding the needs of the business and proactively identifying opportunities that drive financial results
• Act as an internal consultant by providing financial consultation and guidance to business partners as needed; support business in understanding state of finances and tactical/corrective actions required to achieve objectives
• Partner with brand teams on business development opportunities to provide financial/value perspective.  Build Xcel-based financial models to influence and drive negotiations and deal participation
• Conduct forecasting and analysis of marketing and sales expenses in support of business planning deliverables (10-year Business Plan, 3-year Brand Plan, 1-year Tactical Plan/Budget, quarterly corporate forecast submissions)
• Conduct month-end close for brands – review posting of appropriate journal entries by Finance Analysts and provide explanations on variance/performance drivers to Nutropin and Pulmozyme Brand Teams
• Monitor compliance with financial policies and recommend/take actions as needed
• Prepare and present financial reports requiring translation of complex quantitative data to multiple levels of business partners
• Conduct financial data mining and value-based business analysis to provide insights and guidance in support of business decisions and objectives
• Build and maintain effective partnerships with Product Managers, Marketing Directors, Franchise VPs as appropriate, and others within Commercial Finance
• Support strategic projects for IMPACT and Commercial Finance as needed to inform business decisions
• Mentor and develop Financial Analysts (indirect report)
• Participate in process improvement initiatives within Commercial Finance

COMPETENCIES

• Demonstrates theoretical/financial and cross-functional understanding in financial problem solving; works effectively on issues where analysis of situations or data requires in-depth evaluations of variable factors with intra-Commercial impact; demonstrates judgment in selecting methods and techniques to solve routine financial and tactical problems of moderate scope and complexity; contributes sound ideas in developing recommendations for more complex problems; anticipates problems and offers solutions
• Solid experience and facility with distilling business development and M&A situations into key drivers that can be modeled in Xcel
• Interacts and collaborates effectively within workgroup and area of expertise; participates effectively on cross-functional teams; offers views and actively solicits ideas from others in seeking sound business solutions; encourages others in fostering effective teamwork; demonstrates very strong customer service orientation
• Gets point across clearly, with straightforward language, both verbally and in writing; considers the needs and interests of others and incorporates information relevant to them in communications; readily grasps the main points in communications from others
• Plans, prioritizes and reports status on tasks; operates independently with limited supervision, holding self accountable to fulfill assigned tasks and achieve results within timelines; establishes own work priorities and timelines within scope of authority; responds to requests with appropriate urgency and an organized approach; may provide guidance and coordinate work activities of others
• Monitors process effectiveness and efficiency against goals and objectives, taking corrective action as necessary; identifies, implements, and supports complex process improvements
• Understands strategic priorities developed by upper management; recognizes relationship between workplace results and what caused them; able to shift between tactical and strategic perspectives based on audience and project needs

...

Position Summary:

Provide Project and Program Management for IT business solutions that have significant impact to the enterprise in North America ERP Demand to Supply, Manage Finance, and Order to Cash solutions.

The position will work closely with the North American ERP organization to plan, manage and deliver process and system initiatives. As a senior project manager this individual will lead the deployment of SAP systems and processes across Pharma in the North American region. Responsibilities include future SAP site implementations, enhancements, functional transformation projects and infrastructure related projects.

This position provides expertise needed to effectively implement projects and continuously improve processes. This individual will also partner with business project managers while working with the Pharma IT organization to drive requirements and successfully complete projects.

The purpose of the department is to a) provide IT services for the NA regional ERP solutions, b) deliver enhancements and projects for the regional ERP solutions, c) ensure the services are delivered to established customer SLAs, and d) provide a local/regional presence for the ERP IT group.

2-3 most important contributions of this department

Understand the local and regional business needs for the ERP solutions. 
Deliver operational services for the regional and local Demand to Supply, Manage Finance, and Order to Cash solutions.
Deliver enhancements and projects for the Regional Demand to Supply, Manage Finance, and Order to Cash solutions.

Main customers are the regional/local Finance group, regional/local Tech Ops group,  Local Order to Cash group.

Main PI collaborations are with ERP Architecture, global ERP Solution Owners, Business Project managers, IT Application Technical Leads,  AE&O.

Major Responsibilities:

• Developing work plans, managing deadlines and coordination of project team and sub-team activities
• Estimating project skill requirements, and then working with resource deployment managers to identify appropriate resources and manage their integration into the team
• Defining and agreeing on deliverables , risk management and milestones
• Setting and controlling scope
• Communicating status and vision to client management and stakeholders
• Create a collaborative environment which promotes communication across the organization, at all levels: including but not limited to the Steering Committee, Enterprise Architecture, Departmental Managers and Information Technology.
• Provides overall team management, including regular evaluations
• Prepares and delivers executive presentations and facilitates workshops/meetings.
• Ensures procurement and sourcing procedures are followed.
• Provides Functional Manager with feedback on team member performance.

...

 

Description Main Purpose of the Position:

• Direct Quality support staff and operations in accordance with cGMP regulations and Roche standards.
• Provide leadership and guidance to immediate staff hosting inspections or performing Quality Systems functions as assigned.
• Provide the Director, GQIM, with expertise in device and/or combination product inspection issues and risks.

Job Duties/Responsibilities:

• Optimize resources with the PTQS department.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget.
• Monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Roche Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical

Duties/Responsibilities:

• Develop and oversee implementation of the Inspection Risk and Readiness systems to ensure on-going inspection readiness.
• Collaborate with Pharma Technical Operations and Quality areas as needed to identify inspection risks and mitigation plans.
• Serve as a GQIM primary point of contact and liaison for assigned sites
• Manage and oversee the inspection readiness program across sites to ensure proper deployment and reporting of inspection risks
• Lead or support regulatory inspections as appropriate.
• Collaborate with sites to develop and communicate inspection strategy, approach and goals.
• Communicate potential inspection risks and current state of inspection readiness to Senior Management.
• Provide input into the design and presentation of inspection readiness performance metrics
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy.
• Attend and participate in external regulatory and/or compliance organizations, and applicable industry conferences to exchange information regarding current regulatory inspections and to stay current on inspection trends.

...

Job Duties/Responsibilities

• Leads the development, planning, directing and tracking of the validation of GxP computer systems operated by North American ERP team (i.e. SAP ERP, BW, APO, XI, Solution Manager, GRC, Portal and Business Objects).
• Responsible for the quality systems and processes that ensure computer systems are operated and maintained a validated state. This includes all modifications and / or changes to systems or processes, change control, periodic revalidation activities and ensures a continual state of inspection readiness with regard to cGxP’s.
• Leads the Information Technology and Quality team members to develop and implement validation strategies in accordance with company policies, directives and government regulations.
• Develops and writes validation project plans, master validation protocols, acceptance criteria traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
• Leads fellow technical and analysis team members in ensuring quality systems and processed are in compliance with corporate quality directives, policies, standards and procedures.
• Responsible for the maintenance of departmental quality systems and procedures to assure compliance with new and revised corporate standards and policies.
• Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies for the orth American SAP systems.
• Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
• Reviews and approves validation data to assure protocol acceptance criteria is achieved and all deviations are completed and recorded according to procedures.
• Ensure all final reports are completed according to procedure.
• Coordinate and manage the application release cycle processes.
• Manage the life cycle documentation.
• Recommends methods for process improvement, detailing process strengths and weakness of existing and proposed procedures and controls
• Participate in internal and external vendor audits and regulatory audit teams.
• Define and maintain GxP training program to support compliance requirements for IT staff.

...

We are seeking a candidate for a postdoctoral position in the Department of Molecular Biology, to investigate vascular processes.  Research topics include Notch, BMP, Tie2 and EphB4 signaling pathways, and roles of microRNAs in vascular biology.

...