PSOQ Audit, Inspection Management, Regulatory Surveillance Strategic Process Lead

Pfizer

Quality position overseeing PharmSci Audit, Inspection and Regulatory Surveillance processes at Pfizer. Collaborating with regulatory teams to ensure compliance and quality standards.

Posted 4/16/2026full-timeRemote • Montana • 🇺🇸 United StatesSenior💰 $124,400 - $207,400 per yearWebsite

About the role

Key responsibilities & impact

Lead, develop and support execution of PharmSci Audit strategic plan
Work in partnership with RQA on the internal audit plan
Analyze data to support audit and inspection management, regulatory compliance, and strategic planning
Ensure that the audit, inspection management and regulatory surveillance quality systems are a competitive advantage for PharmSci
Collaborate across the PharmSci network to standardize practices
Implement strategies for performance improvement and deploy metrics to determine effectiveness
Partner with PharmSci Business Lines, RQA and PGS to develop procedures and plans for audits, inspections and regulatory information management
Support the management of audit, inspection and regulatory information systems for PharmSci
Function as a Quality System Subject Matter Expert

Requirements

What you’ll need

BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience
Audit Certification, management and performance
Strong Board of Health, Regulatory and Audit experience
Strong GMP/GDP audit, inspection and quality oversight skills
Strong project management, organization, and planning skills
Excellent written and verbal communication and collaboration skills
A Master's degree with relevant pharmaceutical experience (preferred)
ISO Audit experience (preferred)
Strong analytical and problem-solving skills (preferred)
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot (preferred)

Benefits

Comp & perks

401(k) plan with Pfizer Matching Contributions
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

audit managementregulatory complianceGMPGDPperformance improvementdata analysisproject managementquality oversightISO auditstrategic planning

Soft Skills

collaborationcommunicationorganizationplanninganalytical skillsproblem-solving

Certifications

Audit Certification