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