Pfizer
To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.
10,000+
💰 Post-IPO Debt on 2023-05
Manager - Auditor, GCP
October 12
Pfizer
To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.
10,000+
💰 Post-IPO Debt on 2023-05
Description
• Responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GCP portfolio/programs/entities. • Responsible for GCP Oversight and for assuring compliance of projects, products, and programs with Pfizer SOPs, policies, and all applicable regulations and guidelines. • Assesses compliance of GCP clinical trial sites and processes. • Independently conducts more complex routine/non-routine investigator site audits. • Supports and executes on quality programs related to functional areas and vendor entities.
Requirements
• Bachelors or equivalent • 5+ years of operational or auditing experience • Demonstrates knowledge of ICH GCP and global regulations • Demonstrates solid working knowledge of business concepts and quality operations • Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge • Understands quality and auditing frameworks and application • Exhibits proficient organizational and project management skills • Demonstrates technical writing skills • Ability to identify trends within data and apply insights to make recommendations • Understands Regulatory environment with the ability to interpret and apply regulations • Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes • Ability to synthesize information and draw conclusions • Experience evaluating and understanding quality standards or their application • Acts as SME in specific specialty (e.g. gene therapy, non-interventional studies, etc.)
Benefits
• 401(k) plan with Pfizer Matching Contributions • Additional 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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