Inspection Management Team Lead

Use Your Power for Purpose

In this role at Pfizer, you will have an impactful role in improving patients' lives by ensuring our practices adhere to the highest standards of compliance and ethics. Your expertise will help us maintain our commitment to patient safety and regulatory excellence.

What You Will Achieve

The Inspection Management Team Lead supports Pfizer by (as required) preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners (LP), as appropriate. In addition, the Inspection Management Team Lead coordinates Pfizer responses to such inspections and LP audits, strategizing with stakeholders and legal and guiding the functional teams to ensure optimal responses. The Inspection Management Team Lead acts as a RQA sponsor/lead in cross-functional projects, as appropriate. This role leads and develops a team of high performing Inspection Management Leads and ensures that quality standards are consistently applied across all inspections and LP audits. The Inspection Management Team Lead helps guide, develop, and mentor Inspection Management Leads to facilitate their growth of talent. The Inspection Management Team Lead is knowledgeable with current regulatory/health authority trends and brings a unique understanding/perspective relative to regulatory/compliance investigations. The Inspection Management Team Lead serves as the delegate of the Head of Inspection Management.

Role Responsibilities

Leadership

• Collaborates with business stakeholders, including senior business leaders, to instill a culture of regulatory compliance and ensures effective and efficient management of inspection activities

• Interfaces with functional groups within RQA and customers to build knowledge of GCP/PV/GLP regulations and guidelines, and routinely engages in influencing the external environment through appropriate RQA activities (e.g. review of guidelines)

• Builds effective customer relationships across stakeholders and business lines

• Holds their team accountable for responsibilities

• Drives team excellence by initiating and investing in development to build a stronger and more capable organization

• Responsible for performance management

• Strengthens group business acumen by providing opportunities to analyze and solve strategic business issues

• Provides appropriate ongoing support to ensure that current talent develops the skills necessary to be high performing RQA professionals

Risk/Quality Management

• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Pfizer

• Ensures awareness of external trends from regulators & competitors are clearly identified and proactively assessed and followed through on for Pfizer

• Acts as a strategic partner by proactively identifying risks and challenges with regards to inspection findings

• Represents Pfizer in external meetings and conferences as required

• Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance

Operational Excellence:

• Partners with other RQA Inspection Management Leads, Portfolio Team Leads, PCO Regional Team Leads, and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation; Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique)

• Leads pre-inspection visits of investigator sites

• Leads and/or supports management of local or global HA/RA inspections (GCP/GPvP, GLP as appropriate) and ensures that roles and responsibilities are defined and assigned for each inspection; Assumes a leadership role or other supportive roles during the inspection as required

• Leads and/or supports management of local or global LP audits; Assumes a leadership role or other supportive roles during the audit as required

• Lead the control room in any inspection/LP audit and serve as the note taker as required

• Works with members of the inspection team and other colleagues (including, but not limited to, Head of Inspection Management, Head of RQA and Legal) to ensure optimum responses are