Director, Quality Management Systems/Validation & Compliance Lead

About the role

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 position supports GWE R&D by driving strategy, compliance requirements, control, quality, and continuous improvements. 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. In addition, the Director is responsible for assuring compliance with corporate policies for GWE R&D.

Responsibilities

• Assures compliance for all site facility cGLP, cGCP, cGMP and other non-EHS compliance systems and activities
• Has 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 reports 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
• Monitors and drives completion of quality review corrective actions
• Engages site stakeholders including GWE colleagues, strategic partners, vendors, customers, and other resources in the development of the area Compliance Program
• Ensures the consistent application of and adherence to the Compliance Program across all GWE R&D area functions
• Ensures the GWE R&D area Compliance Program complements existing PRD and ORD programs
• Monitors the overall Compliance Program effectiveness and identifies and implements changes based on efficiencies/changing business needs
• Identifies and leads area 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
• Serves as global contact for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance Program
• Serves as global point of contact for interpretation of all functional elements of the GWE R&D Compliance Program
• Facilitates development of annual GWE R&D compliance-related objectives and goals
• Conducts Site Risk Management Reviews and reports on the status and recommends 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 and GWE R&D Leadership
• 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 a relevant discipline and 8+ years of relevant work experience
• Master’s Degree in a relevant discipline (preferred)
• 15 years of experience in facility management, engineering, or compliance-related area of the pharmaceutical business

Skills

• 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
• Ability to translate customer needs into action and meet customer needs
• Ability to ensure business continuity and develop appropriate business contingencies
• Ability to create and implement strategy in own work area
• Ability to create an environment in which Pfizer core values are valued through leading by example
• Ability to advise and influence senior management and colleagues to ensure high performance
• Responsible for developing and training 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
• Proven experience with a bottom-line focus and ability to implement in own work area to demonstrate cost savings and efficiencies
• Track record with experience at senior level
• Ability to demonstrate a professional career and subject matter expertise within Facility Management and Quality Management Systems
• Experience 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, 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
• 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

Physical/Mental Requirements

Due to the nature of work assignments, incumbents must be able to perform detailed work on multiple, concurrent tasks, with frequent interruptions and under time constraints. On a daily basis, the position responsibilities may require the ability to:

• Stoop, reach, stand, and walk the site for extended periods of time
• Push and/or pull objects weighing up to 30 pounds
• Lift and carry objects weighing up to 15 pounds
• Use finger dexterity to operate a computer and other office equipment and hand strength to grasp objects
• Perceive the attributes of objects by touch
• Hear and verbally exchange ideas and information with colleagues and others on the phone and in the office
• See clearly from less than one foot to arm’s length with a good field of vision and to distinguish basic colors and shades of color

On a frequent basis, essential duties of the position may require the ability to climb stairs, to kneel and/or crouch to retrieve items.

Work Schedule, Travel, or Environment Requirements

• Day shift with occasional after-hours or weekend response required
• Periodic travel may be required in support of GWE business needs
• Respond to the site in support of business continuity, emergency response, and off-shift schedules periodically
• Entry and work in laboratory spaces, GxP aseptic space, mechanical/electrical rooms, Central Utility Plant, service areas such as maintenance shops, shipping and receiving, service corridors with adherence to personal protective equipment practices and procedures as well as aseptic gowning and procedures

Work Location Assignment: Hybrid

Pay

The annual base salary for this position ranges from $162,900.00 to $271,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in the share-based long-term incentive program.

Benefits

• 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
• Health benefits including medical, prescription drug, dental, and vision coverage