Director of CMC Quality

Job Summary

To support a growing clinical-stage biotechnology company, the remote Director of CMC Quality will provide quality oversight and direction to vendors, ensuring compliance with cGMPs for drug substance, drug product, and finished product throughout the manufacturing and distribution process.

Key responsibilities:

• Ensure compliance of manufacturing operations at Contract Manufacturing Organizations (CMOs) with regulatory requirements and internal quality standards
• Lead clinical lot disposition and batch record review, ensuring compliance with procedures and regional requirements for product release
• Conduct cGMP audits of vendors and oversee quality systems activities, including deviations and investigations, ensuring timely execution and closure

Required qualifications:

• BA/BS degree in Chemistry, Biology, or Life Sciences with at least 8 years of pharmaceutical industry experience
• Demonstrated knowledge of Quality Systems and cGMP within a regulated environment
• Auditing experience and quality oversight of CMOs, including batch review and issue resolution
• Strong analytical skills with experience in identifying key performance metrics and quality indicators
• Experience in fast-paced, start-up environments, with proven leadership and negotiation skills