CMC Quality Manager

Job Summary

Supporting quality oversight of vendors, the remote Manager, CMC Quality will manage batch record review and product disposition to ensure compliance with cGMPs for drug substance and product in Pulmovant's global clinical development program.

Key responsibilities

• Lead batch record review and clinical lot disposition, ensuring compliance with procedures and cGMPs
• Support QP certification and release activities at contract manufacturing partners for ex-US clinical trials
• Oversee GMP Quality Systems activities at external partners, ensuring timely resolution of deviations and investigations

Required qualifications

• BA/BS degree in Chemistry, Biology, or Life Sciences with at least 4 years of experience in the pharmaceutical industry
• Demonstrated knowledge of Quality Systems and cGMP within a regulated environment
• Hands-on experience with batch record review and product disposition for clinical or commercial pharmaceutical products
• Working knowledge of Good Distribution Practices and ex-US clinical supply requirements preferred
• Experience with deviation, investigation, CAPA, and change control processes at CMOs