Pharmaceutical Vendor Audit QA Manager

Job Description

Because of rapid growth, our client needs a Quality Assurance Audit Manager.

In this position, you will be responsible for the vendor management program, including GMP/GCP audits of contracted organizations. Responsibilities include hosting or assisting with client audits and regulatory inspections, managing the vendor qualification and oversight programs, conducting/managing audits of vendors, including CMOs (drug product, API and raw material), CROs, contract packagers, contract laboratories, and distributors. Processes audited include sterile production, biotech manufacturing, solid oral dose and ointment manufacturing. This position may assist with product disposition and quality agreements, as needed, as well as review of investigations and improving/creating SOPs to support the vendor management process.

Qualifications - Skills & Requirements

• Highly organized with great attention to detail
• Strong computer skills, including MS Office (Word, Excel, PowerPoint); SharePoint
• Strong knowledge of global regulations for commercial & clinical operations
• Travel approximately 10-20% both domestic and international
• Perform additional duties as assigned by department management
  
  

Education & Experience

• 7 years experience in Pharmaceutical Quality Assurance required
• 5 years experience performing GMP audits required
• Experience with GMP & GCP audits preferred
• Bachelor’s Degree from an accredited university