Manager, CMC Quality, Pulmovant

Pulmovant

7d

About The Position

The Manager, CMC Quality supports quality oversight of Pulmovant’s vendors to ensure drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs). Reporting to the Director, CMC Quality, this individual contributor focuses on batch record review and product disposition for Pulmovant’s global clinical development program. The role is suited to someone comfortable working hands-on in a small-company environment, applying a practical, detail-oriented approach to release decisions and quality systems at external partners.

Requirements

• BA/BS degree in Chemistry, Biology, or Life Sciences.
• At least 4 years of pharmaceutical industry experience, including GMP quality assurance experience.
• Demonstrated knowledge of Quality Systems and cGMP in a regulated environment.
• Hands-on experience with batch record review and product disposition/release for clinical or commercial pharmaceutical products.
• Experience with deviation, investigation, CAPA, change control, and OOS/OOT processes at CMOs.
• Strong attention to detail and analytical skills, with the ability to apply risk-based decision making to disposition issues.
• Strong interpersonal skills and the ability to influence and build rapport across functions and with external partners.
• Excellent organizational and time management skills; ability to manage multiple concurrent batches and tight release timelines.
• Excellent verbal and written communication skills, including the ability to present findings and recommendations clearly and concisely.

Nice To Haves

• Working knowledge of Good Distribution Practices and ex-US clinical supply requirements, such as EU Annex 13 and QP release.
• Familiarity with inhaled drug product, drug substance, and/or clinical packaging and labeling operations.
• Auditing experience.
• Experience in fast-paced start-up environments, including comfort working under pressure, with changing priorities and tight deadlines.

Responsibilities

• Lead batch record review and clinical lot disposition for drug substance, inhaled drug product, and clinical packaging and labeling, ensuring release compliance with Pulmovant procedures, cGMPs, and applicable regional requirements.
• Support QP certification and release activities at contract manufacturing partners for ex-US clinical trials, including preparing batch documentation packages and coordinating release timelines with CMOs, Supply Chain, and Clinical Operations.
• Review executed batch records, certificates of analysis, and associated testing data for accuracy, completeness, and conformance to master batch records, specifications, and registered/IND/IMPD commitments; drive timely resolution of documentation errors and gaps.
• Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations; ensure timely and compliant execution and closure and assess impacts on batch disposition.
• Maintain disposition and batch review tracking and metrics, such as right-first-time, review cycle time, and deviation trends; communicate product quality performance and release status to Quality and cross-functional teams.
• Partner with CMC, Supply Chain, and Regulatory Affairs to assess product quality impacts of events, identify product-specific quality and compliance risks, and support risk-mitigation plans.
• Review and provide quality input on master batch records, specifications, test methods, protocols, reports, and SOPs; support drafting and maintenance of Pulmovant batch release and disposition procedures.
• Support regulatory inspection preparation and ongoing inspection readiness, including batch record and disposition documentation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level