Pfizer

PSOQ Audit, Inspection Management, Regulatory Surveillance Strategic Process Lead

Pfizer

full-time

Posted on:

Location Type: Remote

Location: Montana • United States

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Salary

💰 $124,400 - $207,400 per year

Job Level

Senior

About the role

  • 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

  • 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
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
audit managementregulatory complianceGMPGDPperformance improvementdata analysisproject managementquality oversightISO auditstrategic planning
Soft Skills
collaborationcommunicationorganizationplanninganalytical skillsproblem-solving
Certifications
Audit Certification