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
• Acts as the global point of contact for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance Program
• Facilitates the development of 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

Preferred Qualifications

• 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 of 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
• Track record with experience at senior level
• Experience of managing multi-disciplinary teams
• Ability to perform a highly professional role
• Ability to develop services and implement new policies and strategies
• Proven knowledge/prior experience implementing and managing and maintaining quality systems (e.g., ISO 9000, Malcolm Baldrige, etc.); technical records and six sigma experience a plus
• Demonstrated thorough understanding of GLPs, GCPs and GMPs
• High level of leadership capability and credibility, and ability to influence
• Skilled at team facilitation to build consensus and reach decisions
• Strong, effective, and proactive communicator particularly across global sites and customers
• Knowledge of GWE business functions and/or pharmaceutical R&D line knowledge