Medical Quality Issue & Product Management Lead

The Global Medical Quality Governance (GMQG), Medical Quality Issue & Product Management Lead within Medical Enablement & Quality (MEQ) is accountable for ensuring that Medical provides the mandatory leadership for the Maintenance and Defense (M&D) of the entire product portfolio worldwide.

The lead will be responsible for 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.  

The lead will provide the medical and scientific expertise essential to take informed decisions that may have a significant impact at the enterprise level (financial and reputational) such as the Benefit-Risk assessment of products or recommendation for products recalls of the portfolio.

Accountable for overseeing the leadership of the GMQG centralized Medical Quality Issue management team that conducts quality event investigations for medical quality events in compliance with QMS01 requirements.  Responsible for partnering with GMQG reporting colleagues to track quality event performance with metrics, for stakeholders and MQOC/PVR QOC, as appropriate. 

The position will have the following responsibilities:
 

• Lead the Global Medical Product Evaluation team (GMPE) primarily responsible for the medical/medical affairs activities relating to benefit/risk; rapid response teams and health hazard assessments relating to Pfizer products. Work closely with senior leadership in Safety and Regulatory and represent medical in key decision making relating to the benefit risk of Pfizer products. 
• Ensure that goals are met, and the portfolio is supported with the appropriate medical framework to ensure business success and compliance.  Oversight responsibility and medical point of contact for all (M&D) related issues across the portfolio of products. 
• Responsible for enforcing appropriate processes regarding M&D liaising with Regulatory, Safety, and other functional lines as well as with Medical Affairs & Clinical Development.
• Provide medical leadership in the management of safety issues and safety letters
• Provide a critical review & medical input into communications materials when warranted
• Lead a team based in a low-cost offshore location responsible for conducting selected core medical quality activities related to Maintenance and Defense and other relevant quality activities to be determined.  Responsible for setting KPIs and monitoring the progress of the team.    
• Lead development of tools and processes that ensure smooth, efficient and compliant operations of the offshore team
• Lead issue management activities for medical quality events in compliance with QMS01

Qualifications

• MD, PharmD, or advanced scientific degree is required
• 13+ relevant experience in Global Clinical and Medical affairs, Pharma QMS Development and Management, Regulatory Affairs, Clinical Quality, GCP audit readiness Regulatory Inspections experience is preferred
• Demonstrated in-depth knowledge of relevant processes, compliance, regulatory requirements and other global/local evolving legislation
• Strong GxP Quality Management System development & oversight experience
• Familiarity with pharmaceutical product development
• Experience with medical and/or technical review of submissions to regulatory authorities (EMA/FDA) is highly desirable
• Demonstrated ability to effectively navigate ambiguity (high learning agility), develop a path forward and successfully execute to drive results
• International travel as required in support of GMQG leadership collaboration and/or the offshore responsibilities associated with this role 

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 $219,800.00 to $366,400.00. 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 t