Pharmaceuticals

Quality Assurance Manager

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About the job

Do you have significant Quality Assurance experience in Audit and Vendor Management? Are you looking for a change of environment?

Invenia Group is partnered with a growing biopharmaceutical company, focused on commercializing innovative propriety medications within Hematology-Oncology and several other therapeutic areas including Dermatology, Neurology, and Rare Diseases. Our client is looking for a Quality Assurance Associate or Manager (depending on experience) to join their rapidly expanding business.

Role responsibilities:

If successful, you will focus on managing the internal and external audit functions and assisting with vendor management. You will also be responsible for Audit management & QA / Vendor Management including the following:

  • Managing the audit management process – audit schedules, perform GxP audits (US and international), write audit reports, and manage responses
  • Updating the Approved Vendor List
  • Performing audit report review and approval from third-party auditors
  • Supporting client audits
  • Participating in vendor calls
  • Product disposition
  • Reviewing executed manufacturing/packaging batch record
  • Reviewing and approving deviations/OOS/complaint investigations/change controls
  • Generating consolidated CofA
  • Authoring, reviewing, approving, and updating SOPs, specifications, validations, and vendor documents including Master Batch/Packaging Records
  • Authoring or assisting with Annual Product Reviews and Quality Agreements

What we are looking for:

An ideal candidate would have at least 7 years of experience within Pharmaceutical Quality Assurance including over 5 years performing quality audits. They must hold a Bachelor’s degree and have strong computer skills – Microsoft Office/Oracle is desirable.

If you are interested in proceeding with this opportunity, please apply to find out more.