Senior Director, GCS Inspection & Risk Management Lead

Overview

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming delivery of high quality products. Pfizer, We are one. PGS - Manufacture the Future.

The IRM Lead drives the quality culture in Global Clinical Supply (GCS) by providing strategic leadership, oversight, and continuous improvement of activities integral to GCS quality and compliance. Responsibilities include establishing, managing, and maintaining GCS-wide practices to evolve quality approaches, reduce quality events, and contribute to compliant inspections and audits. Focus areas include quality records management, quality metrics compliance, audits and inspection readiness and governance.

Key objectives: develop talent, ensure Quality Investigation Leads (QILs) and Inspection Readiness Leads (IRLs) are trained and supported; ensure QILs and IRLs follow Pfizer SOPs; provide leadership oversight to matrix colleagues in the GSH hubs; analyze quality data to identify risks; lead or support Quality Governance; act as Subject Matter Expert in quality investigations and inspection readiness; and represent IRM and GCS in cross-functional initiatives.

Line Management

• Manage, lead, and oversee the Inspection Readiness and Quality Investigation functions in IRM, ensuring appropriate training through formal and experience-based assignments.
• Line management of GCS Quality Investigation Leads (QILs), including matrix management of hub colleagues;
  Line management of GCS Inspection Readiness Leads (IRLs);
  Matrix management of the GSH Quality Management Specialists.
• Actively develops and retains talent through focused career development, performance management, and an inclusive culture.
• Leads Hiring, Selection and Training of New Hires, and creates Training Plans for IR Leads and QI Leads.

Quality Investigations

• Main point of contact for all GCS related quality records.
• Works with GCS functional lines, PSOQ and CD&O to ensure appropriate and timely processing and closure of records.
• Supports PSOQ procedural updates as needed, providing IRM and GCS perspectives.
• Reviews and triages GCP QE Assessment notifications with GCS, PSOQ, and CD&O to ensure appropriate processing.
• Determines strategy for documentation of quality issues (Quality Event, Deviation Record, CAPA Record, Change Management); escalates issues to Head of IRM as needed.
• Oversees Quality Record assignments and monitors workload to ensure timely investigations.

Audits & Inspections

• Main point of contact for all GCS related audits and inspections.
• Collaborates with RQA, CA, GCS and CD&O functional lines.
• Leads standing IRM IR meetings to share learnings and discuss past/upcoming audits or inspections.
• Oversees compliance with PTMF requirements and ensures timely submission of documents to support audits/inspections.
• Serves as primary escalation point for audits and inspections, aligning readiness with portfolio strategy.
• Manages workload for Process Audits, Regulatory Inspections, and related findings to ensure timely readiness and resolution.
• Represents IRM and GCS in cross-functional initiatives ensuring preparedness for GCP audits and inspections.
• Oversees quality remediations and follow-up activities; escalates issues as needed.

Subject Matter Expertise

• Represent GCS at Quality Management Review Boards and liaise with other Quality organizations.
• Promote a strong quality culture across GCS and partner interfaces; drive consistency in quality approaches.
• Share and implement best practices; develop partnerships with other functions to ensure alignment and efficiency.
• Develop trending and mitigation plans using quality data; identify areas of concern.
• Digital & Process Innovation
  • Advance tools used by GCS IRM; lead process enhancement efforts; champion automation and intelligent solutions; partner with digital teams.

Leadership

• Part of the IRM LT and GCS eLT; contribute to strategic initiatives to evolve IRM and GCS.

Basic Qualifications

Training & Education

• A minimum of a BA or BS is required; advanced degree in Life Sciences, Pharmacy, or related field preferred.

Prior Experience

• Minimum 15 years of pharmaceutical experience with strong experience in clinical supply chain and clinical studies, GMP/GCP quality, compliance, risk and issue management.
• Experience in Inspection/Audit readiness.
• Experience in quality investigation processes.
• Experience supervising internal resources in a matrix environment.
• Strong knowledge of GMP and GCP requirements and applicable SOPs and regulations.

Skills

• Strong people management, organizational, and planning skills; attention to detail.
• Project management with ability to prioritize multiple complex projects and meet…