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Quality Manager, Quality Assurance

RemoteFull-time3–6 yrsPosted 4 days ago

Mid-level mechanical and production role at Jobgether. Needs 3+ years and a degree. Remote.

About the role

This position focuses on developing and managing risk-based audit strategies, overseeing internal and vendor audits, and driving continuous quality improvement. You will act as a key ambassador for the Quality Assurance function, collaborating with operational teams and external partners to maintain the highest standards of GxP compliance.

What you'll do

  • Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit Universe
  • Lead Quality Assurance activities related to procurement processes and vendor oversight
  • Establish and manage mechanisms for ongoing compliance monitoring with applicable laws, regulations, and industry standards, including EU GVP, US FDA CFRs
  • Partner closely with Vendor Management and operational teams to develop and implement risk-based audit strategies
  • Coordinate and contribute to internal system and vendor audits in accordance with the established Audit Plan

What you need

  • Clinical research
  • GCP
  • Pharmacovigilance
  • Quality control

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