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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management, Compliance, and Inspection Readiness, with a strong focus on developing metrics, KPI reporting, and driving continuous improvement initiatives. Proven ability to lead cross-functional teams and manage multiple projects effectively while ensuring adherence to GMP/GDP standards.
Highest-signal resume keywords
Quality ManagementInspection ReadinessKPI ReportingProgram ManagementGMP/GDP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality SystemsAudit ReadinessCAPA MonitoringRisk ManagementData Analysis
Soft Skills
CommunicationFacilitationStakeholder EngagementConflict ResolutionProblem-Solving
Tools & Technologies
AI ToolsDashboarding SolutionsMicrosoft Copilot
Industry Keywords
Regulated Business OperationsSupplier OversightPharmaceutical IndustryQuality GovernanceOperational Excellence
About the role
Key responsibilities & impact- Lead ESOQ inspection readiness strategy and execution for assigned scope
- Own and coordinate audit planning, self-inspection programs, readiness assessments, inspection simulations and remediation tracking
- Lead Gemba and walkthrough audit programs and translate observations, escalations, actions and learnings into sustainable improvements
- Develop, pilot and support AI-enabled tools or agents for audit preparation, readiness assessments, walkthrough audits and knowledge retrieval
- Establish and maintain ESOQ metrics, KPI reporting, dashboards, trend summaries and executive-level insights
- Coordinate and support Quality Management Review processes
- Drive CAPA monitoring, remediation tracking and effectiveness verification
- Lead cross-network learning from inspections, audits, CAPAs, self-inspections and quality events
- Drive Quality Revolution initiatives for quality culture, capability building, proactive risk management and compliance behaviors
- Apply Quality Risk Management principles to identify, prioritize and mitigate risks
- Strengthen understanding of ESOQ oversight responsibilities for CMOs and suppliers
- Partner with ESOQ, External Supply, Site Quality, CMO/Supplier Quality and enabling functions
- Develop executive-ready updates and inspection readiness summaries highlighting status, risks, decisions needed and business impact
- Travel up to 20%
Requirements
What you’ll need- BA/BS with 6+ years of experience, or MBA/MS with 5+ years of experience, or PhD/JD with 1+ year of experience, or MD/DVM with any years of relevant experience
- Experience in quality, compliance, inspection readiness, audit readiness, operational excellence, supplier/CMO oversight or regulated business operations
- Strong understanding of GMP/GDP expectations, quality systems, inspection practices, audit lifecycle activities or comparable regulated environment requirements
- Experience developing or utilizing metrics, KPI reporting, dashboards or governance frameworks
- Strong program/project management capability
- Strong communication, facilitation and stakeholder engagement skills
- Ability to manage multiple projects
- Strong analytical and problem-solving skills
- Candidates must be authorized to be employed in the U.S. by any employer
- U.S. work visa sponsorship is not available now or in the future
- Position requires permanent work authorization in the United States
- Preferred: Master’s degree coupled with relevant pharmaceutical industry experience
- Preferred: Strong conflict resolution skills
- Preferred: Experience leading cross-functional teams
- Preferred: Ability to influence quality decision-making across all levels
- Preferred: Experience supporting or leading regulatory inspections, customer audits, internal audits, RQA audits, self-inspections or front room/back room readiness activities
- Preferred: Experience with CAPA monitoring, effectiveness verification, remediation tracking, inspection response or quality governance routines
- Preferred: Experience in external supply, supplier quality, CMO oversight or global third-party partner networks
- Preferred: Experience identifying or implementing AI, digital, dashboarding or analytics solutions
- Preferred: Experience using common AI tools, including generative technologies such as Microsoft Copilot
- Preferred: Understanding of responsible AI practices, including risk management and ethical use
Benefits
Comp & perks- Global Performance Plan bonus target of 17.5% of base salary
- 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
- Hybrid work arrangement
- Up to 20% travel
