Director, Quality Management Systems​/Validation & Compliance Lead

Director, Quality Management Systems/Validation & Compliance Lead

• United States
  - Washington – Bothell
• United States
  - New York
  - Pearl River
• United States
  - Missouri
  - St. Louis
  - Chesterfield

People Experience at Pfizer centers around its most valuable asset: its people. From candidates considering Pfizer job openings to colleagues transitioning to Pfizer alums, the People Experience team provides unwavering support throughout the entire journey.

The QMS/V&C Lead is responsible for driving the GWE R&D Compliance Program and Systems across Global sites. The incumbent will oversee, manage, and assure overall adherence to the Compliance Program for GWE R&D and drive GWE’s continuous‑improvement approach to service, customer, and compliance assurance.

The QMS/V&C Lead supports GWE R&D by driving strategy, compliance requirements, control, quality, and continuous improvements. In the Compliance area, the Director provides strategy, management advice, ownership, and guidance to all applicable GWE R&D functions by identifying short‑term and long‑term strategy, daily interpretation, and application of compliance requirements for services managed by GWE R&D. The Director is also responsible for assuring compliance with corporate policies for GWE R&D, leading the design, deployment, training, and subsequent continuous improvement of applicable global functional elements of the Compliance Program, and directing the management of compliance functions (e.g., validation, documentation, and training) in support of cGLPs, cGCPs, cGMPs and other non‑EHS regulatory regulations.

• Assure compliance for all site facility cGLP, cGCP, cGMP, and other non‑EHS compliance systems and activities
• Handle budget responsibility for compliance functions
• Oversee adherence to the GWE R&D document management strategy
• Develop, manage, and report progress to GWE R&D Leaders against the GWE Compliance Program and progress on implementation, gap closure, and strategy
• Develop overall area program documentation and ensure documentation compliance
• Plan, lead, and participate in management system audits, including review report preparation and corrective‑action identification and follow‑through
• Verify corrective‑action requests, monitor evaluation of responses, and determine if corrective action resolves the intent of findings or issues
• Monitor and drive completion of quality‑review corrective actions
• Engage site stakeholders—including GWE colleagues, strategic partners, vendors, and customers—in development of the area Compliance program
• Ensure consistent application of and adherence to the Compliance Program across all GWE R&D area functions
• Ensure the GWE R&D area Compliance Program complements existing PRD and ORD programs
• Monitor overall Compliance Program effectiveness and identify and implement changes based on efficiencies or changing business needs
• Identify and lead area certification/registration efforts for GWE R&D compliance
• Facilitate GWE R&D SME team meetings to develop short‑term and long‑term strategies and policies for applicable functional elements of the Compliance Program
• Act as the global point of contact for interpretation, maintenance, and continuous improvement of functional elements of the GWE R&D Compliance Program
• Facilitate the development of annual GWE R&D compliance‑related objectives and goals
• Conduct Site Risk Management Reviews and report on status and recommend areas of improvement to GWE R&D leadership
• Issue, maintain, and control all site‑level compliance system procedures and related documents
• Provide guidance and feedback to site functional representatives regarding strategy, policy, and documentation activities
• Facilitate development of new approaches to solve site management‑system and business issues
• Prepare comprehensive status reports and presentations for GWE R&D Site Leaders and GWE R&D Leaders
• Liaise with third‑party assessors in the assessment of the department’s Quality Management System
• Ensure appropriate correspondence with all internal and external area customers on any Management‑system‑related matters

• Bachelor’s Degree in a relevant discipline and 8+ years of relevant work…