Quality Manager, Quality Assurance

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

• 3–6 yrs of experience
• Clinical research
• GCP
• Pharmacovigilance
• Quality control
• Any graduate