Manager, Quality Auditing-III

Job Description

Job 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.
• This is a high-impact, independent role requiring deep GMP expertise, strong auditing experience, and the ability to influence stakeholders across a global network.
• The contractor will conduct external audits of contract manufacturers (CMOs), laboratories, warehouses, and material/service providers, as well as internal audits of company sites.
• Audits may be performed onsite, remotely, or via desktop review.

Duties & 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 initiative.
• Contribute to the development and maintenance of:
• Global audit schedules Approved supplier list Audit procedures and tools.
• Support training and onboarding of global auditors.
• Identify and communicate trends, risks, and lessons learned from audit finding.
• 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., Track Wise 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.

Required Qualifications:

• 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 in sterile manufacturing and biologics environments required.
• Strong knowledge of global GMP regulations and guidelines (FDA, EU, ICH).
• Experience with software validation and computerized systems compliance.
• 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 supporting regulatory inspections.
• Auditor certification (e.g., ASQ, RABQSA, or equivalent).
• Familiarity with supplier lifecycle management and risk-based audit strategies.
• Experience working in a global, cross-functional environment.