Manager, Quality Auditing-III

Title: Manager, Quality Auditing-III
Location: Exton PA
Duration: 12+ Months
Pay Range: $45/hr.- $51/hr.

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.

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:
o Global audit schedules
o Approved supplier lists
o Audit procedures and tools
" Support training and onboarding of global auditors
" 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
" Travel: Up to 10% (domestic)
" Work model: Hybrid onsite presence (Exton, PA) required Monday, Tuesday, and Thursday when not traveling

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