Position: Manager, CMC Quality
Summary:The Manager, CMC Quality will support quality oversight of Pulmovant's vendors to ensure that 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 role will focus on batch record review and product disposition for Pulmovant's global clinical development program. The role requires someone who thrives in a small-company environment and is comfortable being hands-on, with a practical, detail-oriented approach to release decisions and quality systems at external partners.
Key Duties and Responsibilities- Lead batch record review and clinical lot disposition for drug substance, drug product (inhaled), and clinical packaging and labeling, ensuring product is released in 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 preparation of batch documentation packages and coordination of 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, ensuring timely and compliant execution and closure and assessing their impact on batch disposition.
- Maintain disposition and batch review tracking and metrics (e.g., right-first-time, review cycle time, deviation trends) and 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 impact 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 the drafting and maintenance of Pulmovant batch release and disposition procedures.
- Support regulatory inspection preparation and ongoing inspection readiness activities, including batch record and disposition documentation.
Education and Experience- BA/BS degree in Chemistry, Biology, or Life Sciences with at least 4 years of experience in the pharmaceutical industry, including GMP quality assurance experience.
Essential Skills and Abilities- Demonstrated knowledge of Quality Systems and cGMP within a regulated environment.
- Hands-on experience with batch record review and product disposition/release for clinical or commercial pharmaceutical products.
- Working knowledge of Good Distribution Practices and of ex-US clinical supply requirements (e.g., EU Annex 13, QP release) preferred.
- Experience with deviation, investigation, CAPA, change control, and OOS/OOT processes at CMOs.
- Familiarity with inhaled drug product, drug substance, and/or clinical packaging and labeling operations preferred.
- Auditing experience preferred.
- Strong attention to detail and analytical skills, with the ability to apply risk-based decision making to disposition issues.
- Strong interpersonal skills with the ability to influence and build rapport across functions and with external partners.
- Excellent organizational and time management skills; able to manage multiple concurrent batches and tight release timelines.
- Excellent verbal and written communication skills; able to present findings and recommendations in a clear, concise format.
- Experience in fast-paced, start-up environments preferred - able to work comfortably under pressure, frequently changing priorities, and tight deadlines.
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