The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to biotherapeutics programs.

Responsibilities:

Successful Scientist candidates will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of biotherapeutics project teams, work closely with Study Monitors, Pathologists and Pharmacokineticists to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired. In addition to activities listed, Senior Scientist candidates will provide independent leadership in the design and implementation of safety assessment strategies for Genentech’s project portfolios and lead or provide support to interdepartmental and cross-industry initiatives. May provide supervision, mentoring, and career development to toxicologists.

Division/Function: 

GPPS-EACM / Service Provider Mgt

Position Purpose: 

Develops and delivers high value sourcing models and outsourcing strategies on the IxRS service category to support the out-sourcing needs of PD, pRED, gRED, GPS and GMA/gMED 

Main Responsibilities and Accountabilities:

In general

* To develop and refine a strategic sourcing plan for the category including determination, implementation and management of the applicable governance structure

* To liaison with Roche stakeholders (PD, pRED, gRED, GPS and GMA/gMED) to ensure that the Biometrics sourcing strategy is aligned with in-house capabilities, with current and future needs and capacity

* To provide advice and guidance to GPPS Contracts & Outsourcing Business Managers in the development and management of key service area domain contracts as well as to provide advice and guidance to project and/or study teams on this category 

* To manage all individual service provider relationships within the category, including contractual (MSAs), vendor performance and issue resolution

* To lead performance management with service providers and to facilitate/expedite issue resolution 

Specific to IxRS Key Service Area:

* To maintain an oversight of the IxRS category including ongoing management of spend and demand (including identification of efficiency and value adding opportunities). This category includes over time oversight of spent for  also ePRO/PRO 

* To act as IxRS subject matter expert; contribute or lead relevant IxRS initiatives (i.e. cross functional working groups), maintain awareness of IxRS services, developments and providers globally 

Primary Purpose of Job (Job Summary)

> Build up and maintain best-in-industry global procurement risk management and business continuity management in close collaboration with GPP Head of Compliance, Sustainability & Supplier Diversity, the Roche Group Risk Advisory Team and the GPP Head of Risk Management.

> Develop risk management strategies, programs, processes, tools and systems that are in line with the Procurement Sustainability program in order to increase the resilience of suppliers involved in the supply of Roche’s medicines and diagnostics to patients and deliver value to stakeholders. 

> Manage and mitigate the risks related to Roche’s suppliers and ensure their commitment to sustainability by including sustainability and risk management into supplier relationship management.   

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Lead Global Pharma Procurement Risk Management and related strategic initiatives

* Deputize Head of Sustainability, Risk Management & Compliance in Risk Mgmt related topics

* Lead the development and roll-out of sustainable procurement risk management  processes, tools, systems and programs in GPP in close collaboration with Group Risk Management and with category, regional and site procurement heads

* Lead the global risk management governance in GPP, including compliance with GPP risk management policies, processes and training of GPP staff

* Align with Diagnostics and IT Procurement on risk management strategy and related topics

Functional Roles & Responsibilities  

* Develop GPP risk management processes, tools, metrics and systems in close collaboration with Roche Group Risk Management, category, regional and site procurement as well as other Group functions involved (e.g., Group SHE, Finance, Legal, Quality)

* Influence Roche overall global sustainability & risk management programs and contribute to DJSI submissions

* Facilitate identification, evaluation and mitigation of procurement risks in close collaboration with Group functions, category, regional and site procurement heads and the related business partners

* Develop and keep up to date training content (including e-learnings) on procurement risk management to GPP staff and collaborate with Dia, IT on this

* Facilitate joint risk assessments of Roche procurement & sourcing teams with suppliers

* Design global business continuity management for GPP including crisis management, incident response plans and war room playbooks and facilitate implementation

* Drive compliance with the GPP Risk Management policies & processes, the Roche Group Risk Management Process and risk-related Roche Group Policies & Directives

* Support the business process managers with identification, evaluation and treatment of procurement risks related to products, materials/ services and/or suppliers in close collaboration with the stakeholders

* Ensure timely communication and reporting about procurement risks with key stakeholders, including Dia & IT Procurement, business partners and external stakeholders

* Build strong network with Group Risk Officer & team, category, regional and site procurement heads and other functions involved (e.g., Group SHE, Finance, Legal, Supply Chain, Quality)

Working Relationships

Key internal interfaces:

* GPP Head Sustainability, Risk Mgmt & Compliance

* Category, Regional & Site Procurement Heads

* Roche Group Risk Officer & team

* Head of PT Integrated Risk Management & team

* Diagnostics & IT Procurement

* Group SHE, Finance, Legal

* Supply Chain, Logistics, Quality 

* Risk Managers in procurement and other functions

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in two or more functional areas and applies expert knowledge of mechanical, scientific principles, processes and biopharmaceutical processing equipment.

Job Responsibilities

Essential

• Provide coaching and training on best practices and compliance to SOPs.

• Prepare solutions for the production process.

• Participate in continuous operational improvement.

• Provide reports to management summarizing goal unit attainment.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Understands the theory, concepts, and regulations behind biopharm technology and processes. 

• A strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.

• Anticipates potential problems and takes preventative action.

• Requires judgment to know when it is necessary to consult with supervisor and/or support groups. 

• Understands how own actions impact others and uses this information in decision-making.

• Operate systems that clean and sterilize tanks and filtration systems. 

• Prepare solutions for the production process.

• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).

• Trouble shoot equipment and process problems.

• Comply with safety requirements, cGMP, SOP and manufacturing documentation.

• Use of automation to perform production operations.

• Provide support to Manufacturing to meet production demands.

• Operate automated systems for equipment operation.

• Assemble and prepare equipment for production.

• Exhibit detail oriented documentation skills.

• Communicate effectively and ability to work in a team environment.

• Exhibit professional interpersonal skills.

• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.

• Operate and clean fixed tank and filtration systems.

• Operate large scale column chromatography systems.

• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch reefed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.

• Perform CIP and SIP.

Lead cross functional project teams to:

- Deliver project goals on budget and on schedule
- Develop customer requirements into an approved project charter
- Analyze business, process and systems performance, and identify improvement opportunities
- Make recommendations to Management based on business case and analyses
- Lead decision making support and make recommendations regarding best options
- Communicate proactively with stakeholders regarding progress, issues and plans for resolution
- Develop and use project plans to coordinate participants and track and report progress
- 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

Competencies:

Job Knowledge and Scope – Applies extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems. Determines methods and procedures on new assignments (defines scope and approach). Occasionally creates course material and delivers advanced lectures to internal and external audiences.

- Collaborative Leadership – Ability to 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. Asks “what can I do to help?”.

- Communication – Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.

- Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt.   Able to synthesize large amount of information.  Able to deliver results despite shifting environment.

- Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.

- Customer focused – Partners with customers, looks ahead to predict future customer needs. Manages expectations.
- Supervision – Work is performed under limited direction. Establishes own work priorities and timelines. May provide guidance and coordinate work activities of other personnel.

- Job Complexity & Decision-making – Develops solutions to a variety of complex problems and initiatives. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data require an in-depth evaluation of variable factors, including inter-organizational impact.

- Interaction – Interacts with senior internal and external personnel on significant matters. Represents the organization as a prime contact on initiatives and projects.  Can facilitate RCA's, lessons learned, K-T analyses and FMEA's.  Can facilitate strategic discussions with leadership teams.

Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. 

Provide GMP compliance expertise to internal and external customers.

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

·         Follow company policies and procedures.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines.

·         Manage competing priorities and allocate, adjust, and optimize assigned department resources.

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Manage department and cross-functional initiatives.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Serve as a technical subject matter expert (SME) in support of department functions.

·         Develop and train personnel and internal customers on relevant business processes.

·         Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.

·         Collaborate and author department policies and procedures.

·         Make decisions that impact the goals and objectives of the department.

·         Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·         Perform any other tasks as requested by Management to support Quality oversight activities.

·         Participates in audits.  Lead audits.  Can develop audit findings that address individual gaps and system gaps.  Can lead all “low risk” and most “high risk” area audits.  Can participate on all high risk audits.  Report requires little or no input from manager.  May be asked to participate in meetings post audit to discuss unresolved issues with Senior Management.

·         Identifies gaps in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations.  Leads teams to remediate or defend identified risks.  Works with customers to develop CAPs and CAs for identified audit findings.  Presents information on outcomes to Sr. Management.

·         Will be assigned compliance opinions.  Needs no guidance from manager on resources / references. Opinion has depth and breadth and requires little or no input from Manager / review team.

·         Identifies gaps in corporate practices, policies and procedures.  Leads efforts to remediate gaps.  Write and or participate in corporate document development.

·         Participates in response development to regulatory inspection observations.  Author responses if assigned. Acts as a SME for GMPC.

·         Participates in FDA Meetings.  Acts as a SME for GMPC.

·         Participate as a GMPC representative in team meetings.  Is a SME on compliance issues. Independently raises compliance issues with the team.  Provides input on issues discussed informing manager of resolution. Communicates issues to manager as necessary.

·         Leads mock PAIs

·         Attends meetin...

Senior Manager, Internal Communications, Corporate Relations

The Position

The Senior Manager, Internal Communications, reports to the Director of Internal Communications within the Corporate Relations function. This position is responsible for providing internal organizational communications consultation and support to (1) Genentech’s Chief Financial Officer and (2) the Senior Vice President, Secretary and Chief Compliance Officer, Genentech and head of Legal Affairs, North America. In addition, this position is responsible for consulting on communications initiatives from these and other G&A functions to our approximately 12,000 employees, and will play a key role in developing business communications for leaders and for key best companies submissions. This individual will interact with the company’s senior executives as well as with peers in Internal Communications, Corporate Relations and internal communicators throughout Genentech and Roche.

Responsibilities

• Prepare and maintain strategic, annual organizational communications plan for the Finance and Legal groups
• Provide communications channel analysis and usage proposal
• Draft, coordinate written communications & presentations for leaders
• Partner on content and theme development for each department's employee forums (e.g. leadership conferences and town halls)
• Advise on layout and develop content for department intranet sites.
• Partner with Finance and Legal leadership teams and HR on major announcements affecting organization/organizational change
• Consult on and/or prepare and execute communications plans for G&A initiatives that influence how our approximately 12,000 employee experience working at Genentech (e.g., IT, Procurement, Site Services, EHS, Security, etc.)
• Prepare written communications for senior leadership (C-suite).
• Write original content for several best companies submissions.

Accountable for developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of the Pharmaceutical Quality system.  Accountable for planning, leading and coordinating activities involved in the implementation, governance, and continual improvement of the Pharmaceutical Technical Operations (PT) Quality Risk Management (QRM) Program including standards, business processes, and tools within the Pharmaceutical Quality System (PQS) to ensure consistent and GMP compliant QRM practices.  Engage in external interactions to influence the development of industry best practices in a manner that provides a competitive and strategic advantage to Roche; monitor the external environment for regulatory changes and emerging issues. 

Lead Knowledge Management and Quality Risk Management function including organizational design and implementation, staffing, talent management, performance management, financial budgeting and financial performance, and execution to meet strategic and operational goal.  Specific focus on developing organizational model to support PQS Knowledge Management program. Direct staff in setting operational objectives and business goals for their respective areas of responsibility. Establish and monitor performance measures and objectives for the function.

Major Responsibilities
• Accountable for the development, deployment, full realization, and continual improvement of the PQS Knowledge Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Includes developing strategy and program to establish processes and tools to manage technical product knowledge and information throughout the product lifecycle in accordance with Knowledge Management as an enabling element of ICH Q10. Specifically includes implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools.

• Accountable for ensuring that the PQS Knowledge Management program is integrated with other PT knowledge management and business intelligence initiatives.  Influence across matrix to drive strategic approach and decisions at a functional and cross-functional levels.

• Accountable for the development, deployment, full realization, and continual improvement of the PT Quality Risk Management Program in alignment with current regulatory expectations and in collaboration with the PT Supply Chain organization. Specifically includes the following: implementation and maintenance of a Quality Requirement, Global Standard and Procedure, business processes, and tools

• Accountable for ensuring integration of QRM throughout the product and process lifecycle, and as an enabler within the Pharmaceutical Quality System (PQS).

• Responsible for proactive identification, assessment and management of Quality and Compliance risk across PT operation to ensure compliance and quality supply to patients.

• Accountable for partnering with customers, key stakeholders and senior management across PT Global Operational Units, Functional Units and sites to a.) communicate and escalate Quality risks, resolve conflicts, and drive value-add risk based processes, pragmatic decisions and practices and b.) ensure the Knowledge Management Program for PQS is appropriately integrated with other knowledge management and business intelligence initiatives across the PT organization.

• Serve as Quality representative to the Integrated Risk Management (IRM) Core Team.  Accountable to work in conjunction with the IRM team to implement, maintain, and continually improve the RM Training and Certification Program.  Ensure all roles involved in QRM activities across all levels of the organization are supported through the RM training and certification program.

• Accountable for implementation, sustainment, and continual improvement of processes that ensure proactive identification and management of Quality and Compliance related risks across PT operations to ensure compliance and quality supply to patients.

• Communicate regularly with appropriate management and decision makers to ensure potential quality or regulatory issues that may affect product quality, patient safety or regulatory compliance are escalated and managed adequately.

• Implement, maintain, and communicate relevant QRM metrics.

• Actively engage in external interactions (including regulatory agencies) to influence the development of industry best practices for QRM in a manner that provides a competitive and strategic advantage to Roche.  Support staff development through targeted participating in industry activities.  Monitor environment...

The intern will work in the global Packaging Development group, supporting the Distribution Technology team by characterizing the mechanical properties of different materials used for packaging in the Roche network. The intern will also be using the information gathered in the laboratory to model those materials in silico, and to identify attributes critical to performance. This will help the Packaging Development group by optimizing the final package design proposed while accelerating development and qualification activities. A final report and presentation are expected at the end of the internship.

The intern will learn how to use multiple test equipment including but not limited to Universal (push and pull) test machines, compression, shock, drop and vibration machines, as well as measurement devices. The intern will also learn how to use software for documenting laboratory results, 3D modeling software and effect modeling software. Finally, the intern will get the opportunity to learn about and support other projects in Packaging Development.

As a product manager, you will be responsible for supporting the preparation, assembly, and review of both product and facility-related Chemistry Manufacturing and Controls (CMC) regulatory submissions.

The successful candidate must have broad regulatory and technical knowledge applied to develop, execute and provide oversight in the execution of complex regulatory initiatives and strategies.

The successful applicant will be required to apply practical scientific understanding of drug substance manufacturing facilities and knowledge of pharmaceutical manufacturing to facilitate the preparation and review of regulatory submissions and ensure compliance with applicable regulations and guidelines. The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities may include leading or participating in departmental operational excellence and business process initiatives.

Self-supervisory with senior management guidance on strategy. Exercises considerable latitude in determining objectives and approaches to assignments.

The Regulatory Manager 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. The incumbent will be interacting with FDA to facilitate timely review and approval of submissions.

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

We are seeking candidates for a postdoctoral fellow position in the Ashkenazi lab to study the molecular mechanisms that control apoptosis activation in response to cell stress. 

Main Purpose of the Position:   
• Manage and develop solutions to complex global QC change control issues and Quality initiatives with inter-organizational and multi-site impact across the Biologics network following cGMP regulations and Roche standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 
• Sign documents for activities as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors as described in Roche Leadership Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Manage the end to end change control process.
• Manage multi-site change control activities for the Biologic OU including but not limited to; Specifications, direct materials, validated systems, methods, qualified equipment, and controlled documents.
• Manage the Review and approve processes for changes. 
• Ensure system and process changes are reflected in appropriate procedures and controlled documents.
• Collaborate with internal departments and across sites to ensure understanding and execution of change control process and procedures.
• Facilitate and contribute to cross-site change management forums. 
• Develop and implement strategies for effectively managing multi-site changes 
• Lead change control process improvement activities
• Promote and provide guidance in Good Documentation Practices.
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Serve as a resource for Change Control knowledge management across site Quality departments.  
• Collaborate with Quality departments in the administration, access, and communication of the Change Control system.
• Manage Record Management and Record Retention program activities and processes.
• Manage the centralized records repository.
• Collaborate with Operational and Quality departments to maintain GMP records.
• Provide metrics and reporting as needed.

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.

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

• 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