Pfizer · 4 hours ago
Senior Director, GCS Inspection & Risk Management Lead
Andover, MA
Full-time
Hybrid
Director/Executive
$215K/yr - $341K/yr
15+ years expPfizer is a leading pharmaceutical company, and they are seeking a Senior Director to drive the quality culture in Global Clinical Supply. The role involves strategic leadership and oversight of quality management activities, ensuring compliance and continuous improvement across GCS operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
No H1B
U.S. Citizen Only
Responsibilities
Manages, leads, and oversees 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 provision of 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
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, bringing the IRM and GCS line perspectives
Supports the review and triage of GCP QE Assessment notifications. Collaborates with GCS, PSOQ, and CD&O functions to ensure appropriate processing as needed
Determines strategy for appropriate documentation of quality issues, i.e., Quality Event, Deviation Record, CAPA Record, Change Management
Escalates issues to Head of IRM, document actions
Oversees Quality Record assignments
Monitors workload and support Quality Investigation Leads to ensure a consistent, compliant, and timely investigation process
Main point of contact for all GCS related audits and inspections
Works with RQA, CA, and GCS and CD&O functional lines
Leads standing internal IRM IR meeting to share learnings and discuss questions related to past and upcoming audits or inspections
Oversee compliance with PTMF requirements, proactively monitoring metrics and communicating to GCS functional lines to ensure timely and quality submission of documents to proactively support audits and inspections
Primary escalation point of contact for audits and inspections, ensuring appropriate focus and level of preparation aligned with portfolio submission strategy
Oversee assignments and monitor Inspection Readiness Lead workload for Process Audits (Regulatory Quality Assurance (RQA), Corporate Audit), Regulatory Inspections (Sponsor and Investigator Site) and RQA Investigator Site Audit Findings (if requested) to ensure a consistent, compliant, and timely readiness and processing of findings
GCS liaison to GCSO Asia International Operations, GCP Quality Group, RQA, and CA (Corporate Audit) for inspection readiness and audit/inspection management functions, ensuring GCS is effectively prepared for GCP audits and inspections, identifying and promoting opportunities to improve overall health of the IR process for clinical supplies, ensuring all queries / observations are addressed
Oversee requests for quality remediations and ensure they are handled in a timely and coordinated manner, managing follow-up activities involving both routine & complex matters
Escalate issues to Head of IRM, document actions
Represent GCS at Quality Management Review Boards and liaise with other Quality organizations to ensure overarching alignment in strategic approach around investigational product
Drive quality culture at all levels within GCS and at partner interfaces, and drive consistency across GCS in approach to quality
Identify, share and implement best practices; ensure consistency in overarching processes & systems, where needed; develop partnerships with key colleagues in other functional areas to ensure ongoing alignment & efficiency
Direct the development and evaluation of trending exercises with available quality data to proactively identify areas of concern and highlight need for mitigation
Progress technological enhancements in tools used by GCS IRM
Evaluate, propose and lead process enhancements efforts
Champions automation initiatives to streamline workflows
Partners with digital representatives to implement intelligent solutions
The IRM Lead is part of the IRM LT and GCS eLT, contributing to driving strategic initiatives to evolve IRM and GCS
Qualification
Required
A minimum of a BA or BS is required, advanced degree in relevant Life Sciences, Pharmacy, or related field
Minimum 15 years of pharmaceutical experience with strong experience in clinical supply chain and clinical studies (including a strong understanding of the related planning and operational processes), GMP/GCP Quality, compliance, risk and issue management
Experience in Inspection/Audit readiness
Experience in quality investigation processes
Experience and demonstrated track record in the management and direct supervision of internal resource
Demonstrated effectiveness working in a multidisciplinary, matrix team environment
Strong risk, quality and/or compliance experience
Strong knowledge of GMP requirements, GCP requirements and applicable SOPs and regulations
Strong people management skills, including developing and coaching others
Strong organizational and planning skills, with a keen attention to detail
Strong project management skills and ability to prioritize multiple and complex projects while meeting targeted deliverables and deadlines
Strong analytical and problem-solving abilities
Ability to work independently with limited guidance
Ability to adapt to changing situations and work well under pressure
Strong and effective verbal and written communication skills. Uses a variety of communication tools and techniques to present complex ideas; anticipates potential objections and influences others
Excellent stakeholder management skills
Ability to lead cross-functional initiatives and drive continuous improvement
Proven ability to function autonomously in a matrix model and in a team environment
Technical proficiency/expertise, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; CoPilot, tools for analysis and graphing; reporting (Spotfire); and systems for document management and learning management
Preferred
Advanced degree in Life Sciences
Thorough understanding of clinical supplies and clinical studies, and of the related planning and operational processes
Thorough knowledge of GMP requirements, GCP requirements and applicable SOPs and regulations
Demonstrated experience in supporting continuous improvement projects
Evidence of strong leadership, influencing, negotiation, and management skills
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
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Leadership Team
Albert Bourla
Chief Executive Officer
Ian Read
Chief Executive Officer
Recent News
2026-01-25
Pharma Letter
2026-01-25
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