Director, Quality Management Systems/Validation & Compliance Lead

ROLE SUMMARYThe 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. 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. In addition, the Director is responsible for assuring compliance with corporate policies for GWE R&D. Lead the design, deployment, training, and subsequent continuous improvement of applicable global functional elements of the Compliance Program. Be responsible to direct the management of compliance functions (e.g., validation, documentation, and training) in support of cGLPs, cGCPs, cGMPs as well as other non-EHS regulatory regulations. The position will work in conjunction with GWE colleagues, contractors, R&D business units, R&D research units, and vendor resources to manage initiatives and assure regulatory compliance.ROLE RESPONSIBILITIESThe major duties and responsibilities for QMS/V&C will include but are not limited to:Assures compliance for all site facility cGLP, cGCP, cGMP and other non-EHS compliance systems and activitiesBudget responsibility for compliance functionsOversees adherence to the GWE R&D document management strategyDevelops, manages, and reports progress to GWE R&D Leaders against the GWE Compliance Program and progress on implementation, gap closure, and strategyDevelops overall area program documentation and ensures documentation compliancePlans, leads, and participates in management system audits, including the preparation of review report and identification of corrective actions and follow throughVerifies corrective action requests, monitors evaluation of responses, and determines if identified corrective action successfully resolves intent of findings/issuesMonitors and drives completion of quality review corrective actionsEngages site stakeholders including GWE colleagues, strategic partners, vendors and customers and other resources in the development of the area Compliance programEnsures the consistent application of and adherence to the Compliance Program across all GWE R&D area functionsEnsures the GWE R&D area Compliance Program compliments existing PRD and ORD programsMonitors the overall Compliance Program effectiveness and identifies and implements changes based on efficiencies/changing business needsIdentifies and leads area certification/registration efforts for the GWE R&D complianceFacilitates 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 ProgramGlobal contact for interpretation, maintenance, and continuous improvement of certain functional elements of the GWE R&D Compliance ProgramGlobal 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 goalsConducts Site Risk Management Reviews and reports on the status and recommend areas of improvement to GWE R&D leadershipIssues, maintains, and controls all site-level compliance system procedures and related documentsProvides guidance and feedback to site functional representatives regarding strategy, policy, and documentation activitiesFacilitates the development of new approaches to solve site management system and business issuesPrepares comprehensive status reports and presentations for GWE R&D Site Leaders, GWE R&D LeaderLiaises with third party assessors in the site assessment of the department’s Quality Management SystemEnsures appropriate correspondence with all internal and external area customers on any Management system-related matters.BASIC QUALIFICATIONSBachelor’s Degree in relevant discipline and 8+ years of relevant work experience.PREFERRED QUALIFICATIONSMaster's Degree in relevant discipline15 year’s experience in facility management, engineering, or compliance related area of pharmaceutical businessFirst class interpersonal skills required to develop effective relationships at all levels throughout the businessProven financial management and analytical skills to ensure the cost-effective provision of business services across PfizerAble to translate customer needs into action and meet needs of customerAble to ensure business continuity and develop appropriate business contingenciesAble to create and implement strategy in own work areaAble to create an environment in which Pfizer core values are valued through leading by example in these valuesCan advise and influence senior management and colleagues to ensure high performanceResponsible for developing and training of staff in own work area to maintain best caliber individualsMINIMUM KNOWLEDGE:Detailed understanding of Facilities Management marketplace, particularly delivery of hard and soft servicesProven financial management experienceHave track record of sustaining effective relationships with customers, and external and internal service providersProven experience of bottom line focus and able to implement in own work area to demonstrate costs savings and efficienciesTrack record with experience at senior levelAble to demonstrate a professional career and subject matter expertise within Facility Management and Quality Management SystemsExperience of managing multi-disciplinary teamsNeed to demonstrate the ability to perform a highly professional roleAbility to develop services and implement new policies and strategiesProven knowledge/prior experience implementing and managing and maintaining quality systems (e.g., ISO 9000, Malcolm Baldrige, etc.); technical records and six sigma experience a plusDemonstrated thorough understanding of GLPs, GCPs and GMPsHigh level of leadership capability and credibility, and ability to influenceSkilled at team facilitation to build consensus and reach decisionsStrong, effective, and proactive communicator particularly across global sites and customersKnowledge of GWE business functions and/or pharmaceutical R&D line knowledgeCandidate 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.PHYSICAL/MENTAL REQUIREMENTSDue 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; to reach; to stand, to walk the site for extended periods of time; to push and/or pull objects weighing up to 30 pounds; to lift and carry objects weighing up to 15 pounds; to use finger dexterity to operate a computer and other office equipment and hand strength to grasp objects; to perceive the attributes of objects by touch; to hear and verbally exchange ideas and information with colleagues and others on the phone and in the office; to 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.NON-STANDARD 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, services 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: HybridLast Date to Apply for Job: 9/7/2026 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 our share based long term incentive program. We offer 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer.U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email View email address on click.appcast.io. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Global Operations SummaryLocation: United States - Connecticut - Groton; United States - Washington – Bothell; United States - Missouri - St. Louis - Chesterfield; United States - New York - Pearl River; North America - Any Pfizer Site; United States - Massachusetts - AndoverType: Full time