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Pfizer logo
Pfizer

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

PSOQ Audit, Inspection Management, Regulatory Surveillance Strategic Process Lead

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1849H1B SponsorCompany SiteLinkedIn

Location

Missouri

Posted

94 days ago

Salary

$124.4K - $207.4K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglish

Job Description

PSOQ Audit, Inspection Management, Regulatory Surveillance Strategic Process Lead

Pfizer

• 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

Job 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

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