Director, Quality Management Systems/Validation & Compliance Lead

About the role

The QMS/V&C Lead is responsible for driving 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.

Responsibilities

• Assures compliance for all site facility cGLP, cGCP, cGMP and other non-EHS compliance systems and activities
• Budget responsibility for compliance functions
• Oversees adherence to the GWE R&D document management strategy
• Develops, manages, and reports progress to GWE R&D Leaders against the GWE Compliance Program and progress on implementation, gap closure, and strategy
• Develops overall area program documentation and ensures documentation compliance
• Plans, leads, and participates in management system audits, including the preparation of review report and identification of corrective actions and follow through
• Verifies corrective action requests, monitors evaluation of responses, and determines if identified corrective action successfully resolves intent of findings/issues
• Makes sure corrective actions are completed
• Makes sure the GWE R&D area Compliance Program compliments existing PRD and ORD programs
• Makes sure the Compliance Program is effective and identifies and implements changes based on efficiencies/changing business needs
• Manages certification/registration efforts for the GWE R&D compliance
• Facilitates GWE R&D SME team meetings in the development of short-term and long-term strategies and policies for applicable functional elements of the GWE R&D Compliance Program
• Manages global contacts for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance Program
• Manages global points of contact for interpretation of all functional elements of the GWE R&D Compliance Program
• Develops annual GWE R&D compliance related objectives and goals
• Conducts Site Risk Management Reviews and reports on the status and recommend areas of improvement to GWE R&D leadership
• Issues, maintains, and controls all site-level compliance system procedures and related documents
• Provides guidance and feedback to site functional representatives regarding strategy, policy, and documentation activities
• Facilitates the development of new approaches to solve site management system and business issues
• Prepares comprehensive status reports and presentations for GWE R&D Site Leaders, GWE R&D Leader
• Liaises with third party assessors in the site assessment of the department’s Quality Management System
• Ensures appropriate correspondence with all internal and external area customers on any Management system-related matters.

Qualifications

• Bachelor’s Degree in relevant discipline and 8+ years of relevant work experience
• Master's Degree in relevant discipline preferred
• 15 years’ experience in facility management, engineering, or compliance related area of pharmaceutical business
• First-class interpersonal skills required to develop effective relationships at all levels throughout the business
• Proven financial management and analytical skills to ensure the cost-effective provision of business services across Pfizer
• Able to translate customer needs into action and meet needs of customer
• Able to ensure business continuity and develop appropriate business contingencies
• Able to create and implement strategy in own work area
• Able to create an environment in which Pfizer core values are valued through leading by example in these values
• Advises and influences senior management and colleagues to ensure high performance
• Develops and trains staff in own work area to maintain best caliber individuals
• Detailed understanding of Facilities Management marketplace, particularly delivery of hard and soft services
• Proven financial management experience
• Track record of sustaining effective relationships with customers, and external and internal service providers
• Experience of managing multi-disciplinary teams
• Thorough understanding of GLPs, GCPs and GMPs
• Leadership capability and credibility, and ability to influence
• Strong, effective, and proactive communicator particularly across global sites and customers
• Knowledge of GWE business functions and/or pharmaceutical R&D line knowledge

Benefits

Pfizer offers 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 to include medical, prescription drug, dental and vision coverage.