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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading compliance and quality management initiatives within GxP-regulated environments, with a strong focus on team development, stakeholder engagement, and continuous improvement. Proficient in translating regulatory expectations into sustainable practices while driving organizational change and capability-building efforts.
Highest-signal resume keywords
GMP Laboratory ExperienceCompliance LeadershipQuality Management SystemsCross-Functional Initiative LeadershipDigital Quality Transformations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CAPA ManagementChange ManagementQuality Risk ManagementAudit ReadinessRegulatory CompliancePerformance ManagementQuality Action PlansEQMS ImplementationTalent DevelopmentInvestigations Management
Soft Skills
Strong CommunicationStakeholder EngagementChange LeadershipFacilitation SkillsTeam Collaboration
Industry Keywords
GxP Regulations21 CFR Part 21021 CFR Part 211ICH GuidelinesQuality CultureOperational ExcellenceRegulated EnvironmentQuality Management ReviewsContinuous ImprovementBiological Testing
About the role
Key responsibilities & impact- Lead the ARD Compliance function, defining strategy, priorities, and resource allocation
- Serve as the primary compliance advisor and strategic business partner to ARD leadership
- Build and develop a high-performing team through coaching, talent development, succession planning, performance management, and an inclusive culture
- Provide leadership and governance for CAPA, investigations, non-conformance management, change management, training compliance, procedural governance, Quality Action Plans, and quality risk management
- Lead audit and inspection readiness activities, including preparation, execution support, response coordination, remediation oversight, and sustainable resolution of observations and commitments
- Lead Quality Management Reviews, compliance councils, governance forums, and management reviews
- Monitor compliance metrics, trends, and quality system health to identify systemic risks and drive interventions
- Partner across scientific, laboratory, quality, operational, and digital organizations to translate regulatory expectations into sustainable practices
- Drive continuous improvement, standardization, simplification, and adoption of digital and AI-enabled capabilities
- Strengthen quality culture through training, communication, consultation, and leadership engagement
Requirements
What you’ll need- BS degree in Biology, Chemistry, or related field with 6+ years of experience in a GMP laboratory or similar field; MS degree with 5+ years, or PhD with 1+ years
- Demonstrated experience leading compliance, quality, regulatory, operational excellence, or related functions within a regulated environment
- Experience leading and developing teams with accountability for talent, performance, and organizational outcomes
- Experience working within GxP-regulated environments and quality management systems
- Experience leading cross-functional initiatives and influencing decisions across multiple organizational levels
- Experience supporting audits, inspections, regulatory interactions, or compliance programs
- Strong communication, facilitation, stakeholder engagement, and change leadership capabilities
- Demonstrated ability to manage complexity, balance competing priorities, and deliver results through others
- Experience supporting research, development, laboratories, quality, manufacturing, or technical organizations
- Experience leading enterprise compliance, quality transformation, governance, or continuous improvement initiatives
- Experience facilitating executive governance reviews, Quality Management Reviews, and risk-management forums
- Experience implementing or sustaining complex quality system processes
- Experience supporting digital quality transformations, eQMS implementations, or AI-enabled compliance solutions
- Experience partnering with Quality Assurance and regulatory-facing organizations
- Demonstrated success leading organizational change and capability-building efforts
- Self-motivated and highly effective in a team-based environment
- Effective oral and written communication skills
- Familiarity with 21 CFR Part 210 and 211, ICH and Compendia guidelines (USP, EP, JP) within the framework of QC biological testing is preferred
- Position requires occasional light lifting and periods of standing, sitting or walking
- Some occasional travel to other Pfizer sites is possible
- Overtime, off shift coverage, or holiday coverage, though rare, may be required
- Candidates must be authorized to be employed in the U.S. by any employer
- U.S. work visa sponsorship is not available for this role now or in the future
- Requires permanent work authorization in the United States
Benefits
Comp & perks- Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of base salary
- Eligibility to participate in Pfizer’s share based long term incentive program
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility
