Key skills
AIProject ManagementStrategic PlanningCommunicationCollaboration
About this role
Role Overview
- 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