Job Description
Job Description
We are looking for a Quality Auditing professional with strong GMP auditing experience in the pharmaceutical/biotech industry.
Work Model: Hybrid – onsite Monday, Tuesday & Thursday in Exton, PA
Travel: Up to 10% domestic
Role Summary:
Support global audit programs by conducting risk-based audits of CMOs, suppliers, laboratories, warehouses, and internal sites to ensure compliance with GMP and regulatory requirements.
Responsibilities:
• Lead external/internal GMP audits and supplier audits
• Conduct risk-based assessments for CMOs, partners, and vendors
• Support audit planning, execution, reporting, and CAPA follow-up
• Prepare audit reports and maintain audit records in QMS systems (TrackWise or similar)
• Support regulatory inspections (FDA/EMA) and inspection readiness activities
• Partner with Quality, Manufacturing, and Supply Chain teams on compliance matters
Required Skills:
• Bachelor’s degree in Chemistry, Biochemistry, or related field
• 5+ years of GMP auditing experience in pharma/biotech
• Experience leading audits and supporting regulatory inspections
• Strong knowledge of FDA, EU GMP, and ICH guidelines
• Experience with supplier/CMO audits and risk-based auditing
• Strong communication, analytical, and stakeholder management skills
Preferred:
• Biologics/sterile manufacturing audit experience
• ASQ/RABQSA auditor certification
• Experience with computerized systems compliance and supplier lifecycle management
Company DescriptionLanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
Company Description
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.