Quality Assurance Audit Manager

Job Title: Quality Assurance Audit Manager
Shift: On-Site (Full-Time)
Location: East Windsor, NJ
Duration: Perm Role
 
Role Overview:
The Quality Assurance Audit Manager is responsible for managing the vendor qualification and oversight programs, conducting GMP/GCP audits, and supporting regulatory inspections. This role involves auditing vendors, including CMOs, CROs, contract packagers, laboratories, and distributors, ensuring compliance with global regulations. The position also supports quality assurance functions such as product disposition, SOP development, and investigation reviews.
 
Key Responsibilities:
Vendor Management (Primary Focus)

• Oversee the vendor management program, including vendor qualification and oversight.
• Develop and manage audit schedules, conduct domestic and international GxP audits, and report findings.
• Maintain and update the Vendor List and Approved Vendor List.
• Review and approve audit reports, including those conducted by third-party auditors.
• Host or support client audits and regulatory inspections.

 
Quality Assurance (Secondary Responsibilities)

• Review batch records and assist with product disposition as needed.
• Assess deviations, OOS results, complaints, and change controls.
• Review, author, or update SOPs and Quality Agreements.
• Conduct internal audits and support regulatory inspections or marketing partner audits.

 
Qualifications & Skills:
Education: Bachelor’s degree from an accredited university.
 
Must have:

• 7+ years in Pharmaceutical Quality Assurance.
• 5+ years performing GMP audits (GCP experience preferred).
• Review batch records and assist with product disposition as needed.
• Oversee the vendor management program, including vendor qualification and oversight.
• Review and approve audit reports, including those conducted by third-party auditors.
• Supports quality assurance functions such as product disposition, SOP development, and investigation reviews

 
Nice to have:

• ASQ Quality Auditor Certification (preferred).
• Strong knowledge of global regulations for clinical and commercial operations.
• Proficiency in MS Office (Word, Excel, PowerPoint) and SharePoint.
• Highly organized with strong attention to detail.

 
Other Requirements:

• Ability to travel 10-20% (domestic & international).
• Additional responsibilities as assigned by management.