Manager, Quality Auditing-III

Position Summary

The Manager, Quality Auditing (Contractor) supports the execution and continuous improvement of the global audit program across the Americas and international operations. This role is responsible for conducting risk-based audits and ensuring that suppliers, partners, and internal sites meet applicable GMP and regulatory requirements.

Responsibilities

• Audit Program Support, Execution & Oversight
• Lead and perform risk-based external audits of CMOs, laboratories, warehouses, and suppliers supporting commercial and clinical products
• Conduct internal audits of company sites to ensure ongoing GMP compliance and inspection readiness
• Support global audit program execution, including cross-regional audit initiatives
• Contribute to the development and maintenance of:
• Global audit schedules
• Approved supplier lists
• Audit procedures and tools
• Identify and communicate trends, risks, and lessons learned from audit findings
• Participate in inspection readiness activities and support regulatory agency inspections (e.g., FDA, EMA) as needed
• Reporting & Compliance
• Independently author clear, concise, and timely audit reports
• Evaluate supplier responses and ensure appropriate follow-up and closure
• Manage audit-related records in quality systems (e.g., TrackWise or equivalent)
• Supplier Quality & Stakeholder Partnership
• Assess supplier suitability and GMP compliance for new and existing partnerships
• Partner with Quality, Manufacturing, and Supply Chain stakeholders to resolve supplier quality issues
• Provide quality input for supplier selection, qualification, and ongoing oversight

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
• Minimum 5+ years of GMP auditing experience in pharmaceutical or biotechnology environments
• Demonstrated experience leading audits and/or supporting regulatory inspections
• Strong knowledge of global GMP regulations and guidelines (FDA, EU, ICH)
• Proven ability to independently assess compliance and make risk-based decisions
• Excellent written and verbal communication skills
• Strong analytical and problem-solving capabilities
• High attention to detail with the ability to manage multiple priorities
• Ability to influence and collaborate across functions and geographies
• Demonstrated independence, sound judgment, and professionalism

Preferred Qualifications

• Experience auditing biologics and sterile manufacturing operations
• Auditor certification (e.g., ASQ, RABQSA, or equivalent)
• Experience with software validation and computerized systems compliance
• Familiarity with supplier lifecycle management and risk-based audit strategies
• Experience working in a global, cross-functional environment