Sr. Competitive Intelligence Manager

 

The Sr. Competitive Intelligence Manager (“CIM”) participates actively in supporting Genentech's US commercial planning efforts by providing objective, in-depth information about current and future markets and competitive forces.  The CIM acts as a strategic advisor to the US commercial teams with deep expertise in current and future competitive drivers in the marketplace as well as functional expertise in how to use CI to develop competitive strategies.

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial, clinical, and scientific competitive information.  Make recommendations on brand strategy that prepare the brand for a competitive marketplace.
• Liaise with global CI counterparts to ensure up-to-date competitive intelligence and assumptions are shared with all appropriate US teams (includes congresses, news flashes, pipeline updates, therapeutic area landscape reviews)
• Collaborate with brand to plan for competitor launches by co-planning local strategy wargames and supporting rigorous competitive readiness plans.
•  Lead competitive threat assessments to develop rigorous team assumptions about key competitors; ensure local assumptions are consistent with global assumptions.
• Provide situational analysis support for quarterly business reviews, brand planning, launch readiness reviews, etc.
• Field intelligence facilitation, including managed care teams
• Work on innovative programs to increase the value of competitive intelligence processes and practice, and analyze the success of these programs.  Liase across the broader Market Analysis & Strategy organization to deliver holistic analytic insights to the brands.  Inform, communicate, and collaborate with MA&S partners.
• Manage one to two direct reports, which will include ongoing coaching and development discussions with tangible action plans for leveraging strengths and addressing areas of growth.

 

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This position is part of the drug product group within Biologics Manufacturing Science and Technology (BMSAT) organization. The successful candidate will work with a team of engineers and manufacturing technical specialist responsible for fill-finish technology transfer to contract/partner manufacturing sites, as well as process transfer between Genentech/Roche manufacturing sites. The successful candidate will also be responsible for providing ongoing technical support for drug product manufacturing processes across the Genentech/Roche network.  Candidate will ensure technical stewardship across the various CMO product transfers as well as ongoing continuous improvement projects. 

• Serve as a technical lead for one or more fill-finish process transfers to contract/partner manufacturing sites, as well as between Genentech/Roche manufacturing sites.
• Provide on-going fill-finish manufacturing support to the CMO or internal manufacturing sites by performing trouble shooting, product impact assessments during deviations and investigations and process improvements. 
• Work collaboratively with the site MSAT groups, Late Stage Pharmaceutical Development groups, Manufacturing Operations, and Engineering to develop in-depth knowledge of the fill-finish processes and to facilitate technology transfers.
• Author and review technical reports, process validation documents, and portions of regulatory submissions to support licensure.
• Identify and communicate manufacturing best practices, and work to ensure manufacturing process consistency across the different fill-finish facilities.
• Lead and participate in cross-site and cross-functional teams responsible for technical oversight of drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
• Lead and/or guide the product technical teams (PTTs), serve as a member of the PTT, collaborate closely with the product supply chain, quality and regulatory lead.  Participate in Joint Management Teams (JMT) for CMO transfers for functional representation and/or team updates.

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The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

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This position is responsible for providing leadership and direction to a purification process development group in Purification Development.  The candidate will lead a team of 12-18 staff comprised of several groups of scientists and engineers and be responsible for the management and leadership of multiple early stage and late stage development and technology projects.  A high degree of initiative is expected to assess new areas and directions critical for Pharma Technical Development and Genentech’s future success.  Strong management skills to lead, motivate, and develop staff in their group is a key requirement for this position.  The candidate is expected to provide leadership to their groups and throughout Purification Development and across Pharma Technical Development.

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Manage selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Ensure effective training program exists, improve with time, and are managed in compliance with PQS
• Ensure all employees have developmental goals and barriers removed to support attainment of goals
• Drive continuous improvement initiatives which simplify processes, enabling improvement in right-firtst-time, and appropriate prioritization of high compliance risks
• Manage and prioritize resources through IMPACT and in alignment with associated IMPACT prioritization priciples
• Ensure projects and initiatives are completed on time and within budget.
• Collaborate, influence and/or author department policies and procedures.
• At the cross-site and corporate level, provide leadership, vision and direction to:
­ address complex validation issues and influence network direction
­ develop and maintain validation programs  within cGMP regulations and the PQS.
• Monitor and control expenditures against the department budget.
• Immediately escalate potential quality or regulatory issues that may impact product quality or regulatory compliance.

Technical Duties/Responsibilities:
• Provide direction to subordinates in order to provide effective oversight of all validation systems lifecycle deliverables, per PQS.
• Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.
• Ensure that the Quality Leadership Team is aware of significant validation issues that may impact product quality or operations.
• Maintain and present validation systems health, representing the health of the program.
• Serve as technical and strategic resource for a range of validation assignments.
• Review and approve regulatory submissions and present validations to regulatory authorities during routine and pre-approval inspections.

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The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

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The senior DBA manager leads and manages a staff of Database Administrator (DBA) professionals for Genentech database environment that includes Oracle and SQL Server. The individual will work with other global IT team leaders to translate the organization's IT strategy into specific database roadmaps and deliverables, measures the effectiveness of the delivery model, and track progress against plan and operational Service Level Agreements (SLA). The individual will provide management and implementation of strategic initiatives for the enterprise databases services in the charge toward efficiency and optimization. In addition, the individual is responsible for developing processes and procedures for overall IT Operations, upgrading and maintaining IT processes,production controls, capacity planning, and system backups and recovery. 

Key Strategic Objectives

* Lead the organization through organizational change, technology transformation, and sustained growth while exhibiting excellent judgment on how to prioritize between operational excellence and financial prudence

* Drive successful creation of a strong team dynamic in a collaborated and risk-taking

culture. Translate the organization's strategy into tactical execution plans replete with key performance measures and monitor the results on regular basis

* Improve Genentech's return on invested capital by having a systematic capacity planning process to maximize the utilization of assets and increase the velocity of infrastructure investment in virtualization and cloud computing.

* Build and develop future leaders of the organizations while advancing Genentech's image as one of the best places to work in America.

Responsibilities:

• The right candidate for this position is well organized, and an exceptional communicator with his/her team, peers, executive management, and the company. 
• This person must be able to lead and manage change. The individual will live by metrics, staying ahead of the tactical while also deeply understanding the needs of various business teams to appropriately plan for growth and change.
• Demonstrated ability to lead and energize multidisciplinary teams with gifted communication and interpersonal skills. 
• Demonstrated analytical, problem-solving and conceptual skills. 
• Ability to analyze project needs and determine resources needed to meet objectives. 
• Demonstrated negotiation skills with vendors or management and ability to influence management regarding matters of significance to the organization. 
• The successful candidate must be able to establish credibility very quickly in organization with shifting priorities. 
• The individual must be a strong leader who can prioritize well, communicate clearly and compellingly and who understands how to drive a high level of focus and excellence with a strong, talented, opinionated team.
• The individual will have a technical aptitude particularly in the database domain and be credible as leader in a technical organization. 
• The individual will be able to articulate with full clarity the aspiration of his teams, and achieve results through influence and leadership rather than direct authority...

The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Network Engineer, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

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Sr. Planning Manager, Access Solutions  Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Manager has an advanced knowledge base regarding Healthcare Compliance and Privacy, or Operational Quality. This position is responsible for leading and maintaining all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, operational quality measures and the management of external business partners. Additional key responsibilities of this role are: compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization on compliance related matters.

• Extensive knowledge of organizational leadership and quality models, theories, tools methodologies and processes.
• Deploy change agent strategies in support of organization-wide continuous improvement efforts. Develop teams and participate on them in various roles
• Develop and maintain organizational focus on the importance of quality and performance excellence. Create quality policies and procedures in support of the strategic plan, and integrate those policies and processes into the tactics developed to support the strategic plan.
• Demonstrate management abilities in human resources, financial, risk, and knowledge management applications. Use effective communication methods in various situations to support continuous improvement efforts. Select and use appropriate tools and methodologies to plan, implement, and evaluate projects. Develop, deploy, and evaluate quality plans that can be used throughout the organization. Evaluate and recommend appropriate quality models or systems to implement in various situations.
• Integrate quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Manage, identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations to leadership the leadership/ senior leadership teams
• Manage outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• Develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as the subject matter expert for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on quality and compliance matters of medium to high risks.
• Represent the company as a primary compliance contact on concerns related to Access Solutions.

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The USMA Manager of Systems and Processes works closely with the business to define strategies for development, implementation and improvement of core business processes and workflows to support the business needs in alignment with local regulations and corporate policies. This includes defining current processes, establishing mechanisms to identify process gaps and develop solutions, establish quality control measures for processes and system data, and coordination of process and quality improvement projects. The Manager of Systems and Processes is responsible for analyzing, refining and developing processes through to implementation and beyond to support decision making by USMA management.

Job Duties/Responsibilities:

• Organize and facilitate teams to critically review current business processes for quality, simplification and effectiveness and to identify requirements requiring cooperation and support from cross-functional stakeholders/business partners, establishing links between business strategy and process improvement initiatives and use of systems.
• Develop procedural documents, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
• Routinely prepares reports by collecting, analyzing and summarizing information to support portfolio planning and study management activities and decisions.
• Collaborates with local or global reporting teams to create USMA specific reports to ensure accurate data is reported to management and enable good business decisions to drive business success.
• Collaborates with USMA stakeholders and other business partners to ensure appropriate documentation and integration in to process maps.
• Regularly attend cross-functional staff meeting to present system and processes project and process improvement activity status.
• Represents USMA on global systems/processes initiatives contributing to maximize functionality and ensuring alignment.
• Serve as internal advisor to address systems/process related questions and gather information to distinguish requests from true business needs.
• Develops tools, templates and procedural documents to support the tactical application of business processes as required.
• Routinely solicits feedback from users on systems and process enhancements, training and other ways of driving more effective systems/processes integration.
• Provides input to training programs and team effort by accomplishing related results as needed.

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Sr. Product Manager

 Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

•  Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share

• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives

• Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share

• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 

• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners

• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility

• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments

• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives

• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
  Complies with all laws, regulations and policies that govern the conduct of GNE activities
  

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We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.

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We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.

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Position Purpose:

• The Senior Regulatory Global Project Manager is expected to serve as a strategic partner with Global Regulatory Leaders (GRLs), work with the GRL and the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions;
• Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team;
• Contributes to the efforts of building templates, tools and processes to optimize filing team performance;
• Serves as business partner for the assigned TA (Therapeutic Area) in PDR, working closely with the TA Head, brings excellent project management service offering to the TAs, and also bring TAs’ request/feedback to the Regulatory Business Excellent (RBE) to help further optimize the performance and service offering by RBE.

Major Responsibilities and Accountabilities:

• Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need;
• Takes accountability for all project management aspects and works effectively and closely with the GRL or Team Leader;
• Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team’s activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources;
• Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders;
• Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PTS of a filing, and work with team to define a mitigation plan;    
• Effectively facilitates filing team meetings with high quality meeting agenda and minutes;
• Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items;
• Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines;
• Maintains proper online documentations of filing related project documents;
• Assists GRL on preparation, organizing and conducting lessons learned sessions post filing;
• Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO’s project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.

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• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities.
• Provide technical review and approve quality risk management and validation/ qualification deliverables for small molecules and biologics equipment qualification, ensuring proper design and execution.
• Ensure that equipment and systems remain in a validated state, and that validation master plans and their related documents are accurate and current.
• Develop strategies and act as project manager for new projects in collaboration with system owners.
• Develop near-term and long-range plans for the department in collaboration with Senior Management.
• Provide technical assessment and approval for GMP changes.
• Assess equipment-related discrepancies and provide input to investigations.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate in audit/inspections as a subject matter expert.
• Support implementation and provide stakeholder feedback and input to the integrated Pharmaceutical Quality System (PQS) documents.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide input into investigations involving GMP related failures.
• Develop and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Advise other IMP QEV staff members on Validation related processes and projects.
• Supervise/oversee temporary or contract staff, as required.

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The Senior Quality Manager is responsible for proactively ensuring that all GCP governed clinical activities in PDG (Product Development Operations) are delivered to the highest standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.

The Senior Quality Manager leads quality and compliance excellence within PDG by embedding quality principles throughout the organization. This is achieved through:

• Close collaboration/partnership with the PD Operational staff
• Facilitation of subject matter experts within and outside PDG
• Strategic liaison with PDQ (global quality group)
• Staying abreast of internal and external developments, trends and other dynamics relevant to the quality and efficiency of PDG

Main duties and responsibilities:

Quality Management System - Analyze and drive the QMS requirements for PDG and Implement, review and manage the QMS and monitor its performance.

Ensure cross functional alignment and compliance through process documents - Analyze/review “to be” processes, forms, templates and related process documents. Coordinate the functional subject matter experts by scheduling review and implementation of new/revised process documents  and develop and maintain effective relationships with other departments to ensure that all controlled document review activities are executed efficiently and effectively.

Risk management strategy - Implement, review and maintain strategic quality risk management activities and implement, review and maintain systems that enable identification of key risks for escalation to study teams and senior management.

Performance metrics -  Implement, review and report the most appropriate key performance indicators (KPIs) for the business and monitor their effectiveness Implement, review and maintain processes that enable oversight for PDG management and personnel on the metrics which give performance data on the chosen KPIs.

Compliance support - Drive the compliance support process for PDG in order to create a compliant workforce and workplace based on Regulator’s requirements. Provide timely GCP and process compliance support to personnel by answering questions and providing advice manage the process for escalation of compliance issues through the appropriate routes and with appropriate urgency.

Additional duties and responsibilities:

• Continuous Improvement
• Training Compliance
• Facilitating simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Lead and/or supervise other key projects as required

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• Manage Quality system for change control and document management functions for GMP changes involving equipment, documents, test methods, processes and specifications for IMP Small Molecule and Biologics operations.
• Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
• Proactively identify, prioritize and assess quality systems compliance risks across the IMP network
• Manage Quality System for discrepancy and CAPA management for IMP customers.
• Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
• Manage workflow through Trackwise discrepancy and CAPA systems
• Manage and oversee GMP self inspection program for IMP manufacturing and testing areas including:
• Maintain plan and schedule for self inspection audits
• Coordinate self inspection audits with other subject matter experts.
• Issue audit reports and track corrective actions from audits.
• Communicate to PTDQ-U leadership regarding compliance status
• Provide Quality oversight to GMP IMP Contract Laboratories/Organizations.
• Maintain list of approved contract testing laboratories and corresponding Quality Agreements
• Provide support for establishing new Quality Agreements, revising or renewing existing Quality Agreements, and periodic review of Quality Agreements
• Participate in lab audits as needed
• Serve as the QA representative on cross-functional and multi-site teams.
• Facilitate continuous improvement and the sharing of best practices at the various IMP global sites
• Provide guidance to internal and external customers on best practices for various Quality Systems.
• Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, and Quality Agreements and or related processes and projects.

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