Medical Quality Excellence Lead

Pfizer

282d • $242,000 - $403,400

About The Position

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 & well-informed 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 cross-functional 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 Pfizer's 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.

Requirements

• Bachelor's degree required with a minimum of 15 years' experience; MBA/Master's with a minimum of 13 years' experience; PharmD/JD with a minimum of 10 years' experience.
• Relevant experience in Global Clinical and Medical affairs, Pharma QMS Development and Management, Regulatory Affairs, Clinical Quality, GCP audit readiness, and Regulatory Inspections.
• In-depth knowledge of Medical Affairs processes, compliance, and regulatory requirements.
• Strong GxP Quality Management System development and oversight experience.
• Familiarity with pharmaceutical product development and non-interventional/observational research studies.
• Experience with medical and/or technical review of submissions to regulatory authorities (EMA/FDA) is highly desirable.
• Demonstrated leadership capabilities including influencing, collaboration, and coaching.

Responsibilities

• Provide strategic direction for quality oversight of Medical Evidence Generation activities.
• Oversee the GMQG centralized Medical Quality Event management team.
• Ensure compliance with QMS01 for medical processes.
• Deliver enterprise quality management system governance.
• Ensure integration and transition plans for evidence generation activities are delivered.
• Work cross-functionally with GMQG leaders for alignment on quality oversight activities.
• Align with MQOC/PVR QOC for optimal process designs.
• Share team performance metrics with GMQG leadership.
• Collaborate with Senior Medical Leaders on regulatory use of RWE data.
• Create KPIs and metrics with MEG Leadership and MQOC.
• Ensure RWE study compliance with Pfizer standards.
• Lead quality event management processes.
• Provide oversight of Medical Evidence Generation study quality monitoring.
• Drive continual improvement strategies for MQOC/PVR QOC.
• Develop and maintain processes for Health Hazard Assessments.
• Serve as the medical point of contact for quality-related issues.
• Lead a diverse team of quality experts.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Participation in Pfizer's Global Performance Plan with a bonus target of 25% of base salary.
• Eligibility for share-based long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree