Manager, Quality Auditing Contractor LC00002
Overview
Lead and execute risk based audits across Americas and international operations. Ensure suppliers meet GMP and regulatory standards. Drive continuous improvement of global audit program.
What You'll Do13
- 1Lead and perform risk based external audits of CMOs laboratories warehouses and suppliers
- 2Conduct internal audits of company sites to maintain GMP compliance
- 3Support global audit program execution including cross regional initiatives
- 4Contribute to development of global audit schedules approved supplier lists and audit procedures
- 5Support training and onboarding of global auditors
- 6Identify and communicate trends risks and lessons learned from audit findings
- 7Participate in inspection readiness activities and support regulatory agency inspections such as FDA EMA
- 8Author clear concise and timely audit reports
- 9Evaluate supplier responses and ensure appropriate follow up and closure
- 10Manage audit related records in quality systems such as TrackWise
- 11Assess supplier suitability and GMP compliance for new and existing partnerships
- 12Partner with Quality Manufacturing and Supply Chain stakeholders to resolve supplier quality issues
- 13Provide quality input for supplier selection qualification and ongoing oversight
Requirements13
- 1Bachelor's degree in Chemistry Biochemistry or related scientific discipline
- 2Minimum 5+ years of GMP auditing experience in pharmaceutical or biotechnology environments
- 3Demonstrated experience leading audits and supporting regulatory inspections
- 4Strong knowledge of global GMP regulations and guidelines FDA EU ICH
- 5Proven ability to independently assess compliance and make risk based decisions
- 6Excellent written and verbal communication skills
- 7High attention to detail with ability to manage multiple priorities
- 8Ability to influence and collaborate across functions and geographies
- 9Travel up to 10 percent domestic required hybrid onsite presence in Exton PA required Monday Tuesday and Thursday
- 10Auditor certification such as ASQ RABQSA or equivalent
- 11Experience with software validation and computerized systems compliance
- 12Familiarity with supplier lifecycle management and risk based audit strategies
- 13Experience working in global cross functional environment
Salary Insight
$94 - $102k per year
Location
Required Skills
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