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

Qualifications:

Bachelor's required and a minimum of 15 years' experience; MBA/Master's 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 in-depth 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 non-interventional/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 $242,000.00 to $403,400.00. In addition, this position is eligible for participation in Pfizer’s 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 life’s 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 | (uscandidates.mypfizerbenefits.com). 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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Quality Assurance and Control