Medical Quality Excellence Lead

The Global Medical Quality Governance (GMQG) Medical Quality Excellence Lead within Medical Enablement & Quality (MEQ) is accountable for providing strategic direction to ensure quality oversight and state of control for identified Medical Evidence Generation activities globally for Medical Evidence Generation & Medical Affairs teams for the following processes: Independent Medical Grants Research Collaborations Pfizer sponsored studies for the generation of RWE data and Rapid Response teams & Health Hazard Assessments relating to Pfizer products ensuring a fair & wellinformed balance in its assessment of decisions for product withdrawals in accordance with REG21 and Medical Executive Committee policies.

Accountable for overseeing the leadership of the GMQG centralized Medical Quality Event management team to ensure compliance with all aspects of QMS01 for medical processes and Evidence Generation Quality Oversight/Monitoring in support of a state of control. Plays a critical role in delivering enterprise quality management system governance & supporting a strong proactive quality culture across medical evidence generation teams. Responsible for ensuring agreed upon Integration and transition plans are delivered for evidence generation activities in accordance with integration/transition plans. Works cross functionally with GMQG leaders to ensure alignment of key quality oversight activities. Responsible for alignment with the MQOC/PVR QOC as part of the Pfizer QMS with crossfunctional partners to identify and create optimal approach and process designs selecting appropriate real world data quality standards and ultimately enable the teams to deliver quality and excellence for medical evidence generation activities. Accountable for sharing the teams performance with metrics to GMQG leadership and MQOC/PVR QOC as appropriate.

Collaborates with Pfizers Senior Medical Leaders to understand and translate health authorities perspectives on the regulatory use of RWE data and evolving RWE guidance as well as develop actionable business processes to ensure high quality and timely delivery of compliant RWE projects. Creates KPIs and metrics with relevant MEG Leadership colleagues and in partnership with the MQOC to ensure alignment and in support of the MQOC risk register. Responsible to ensure RWE study compliance with Pfizer standards.

• Lead quality event management processes for medical quality events
• Provide direct oversight of the Medical Evidence Generation study quality monitoring & audit readiness/remediation program and manage quality events.
• Drive strategies for continual improvement of the MQOC/PVR QOC and support communication to enterprise quality governance.
• Develop and maintain process for Health Hazard Assessments and REG 21 medical responsibilities for certain Pfizer products without dedicated Medical Affairs support.
• Execute the vision for quality oversight and serve as the medical point of contact for all quality related issues related to medical evidence generation
• Accountable to ensure a state of control for medical evidence generation processes liaising with Chief Medical Office Regulatory Safety and other functional lines as appropriate
• Lead a diverse world class team of quality experts and support the professional development goals of GMQG colleagues while fostering a culture of quality and excellence

• Encourage adoption of new technologies and ways of working to drive innovation and operating efficiencies for quality

Qualifications:

• Bachelors required and a minimum of 15 years experience; MBA/Masters and minimum of 13 years experience; PharmD/JD and minimum 10 years experience
• Relevant experience required in Global Clinical and Medical affairs Pharma QMS Development and Management Regulatory Affairs Clinical Quality GCP audit readiness Regulatory Inspections
• Demonstrated indepth knowledge of relevant Medical Affairs processes compliance regulatory requirements and other global/local evolving legislation
• Relevant experience required in Global Clinical and Medical affairs Pharma QMS Development and Management Regulatory Affairs Clinical Quality GCP audit readiness Regulatory Inspections
• Strong GxP Quality Management System development & oversight experience
• Familiarity with pharmaceutical product development; and noninterventional/observational and pragmatic research studies
• Experience with medical and/or technical review of submissions to regulatory authorities (EMA/FDA) is highly desirable

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment:Hybrid

The annual base salary for this position ranges from $242000.00 to $403400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 25.0 of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control