Summary:The Director, CMC Quality will be responsible for providing quality oversight and direction to 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). This is an individual contributor role within a lean QA team, requiring someone who thrives in a small-company environment and is comfortable being hands-on across all aspects of CMC quality. The role demands a strategic yet highly practical approach to quality systems, vendor oversight, and multi-regional regulatory compliance in support of Pulmovant's global clinical development program.
Key Duties & Responsibilities:- Ensure that manufacturing operations at Contract Manufacturing Organizations (CMOs) and partners comply with regulatory requirements and internal Pulmovant quality standards.
- Lead clinical lot disposition and batch record review, ensuring product are released in compliance with Pulmovant procedures, applicable regional requirements, and support QP certification and governance activities at contract manufacturing partners for ex-US clinical trials.
- Oversee GMP Quality Systems activities at external partners, including deviations, investigations, cAPAs, change controls, and OOS/OOT investigations ensuring timely and compliance execution and closure.
- Conduct and document cGMP audits of vendors, CMOs, contract testing laboratories, contract packaging/labeling, and logistics providers. Negotiate and maintain Quality Agreements with external partners.
- Provide quality and technical input to cross-functional project teams, and review internal and external documentation including protocols, reports, test methods, specifications, master batch records, and SOPs.
- Partner with CMC, Supply Chain, and Regulatory Affairs to assess overall product quality performance, identify product-specific quality and compliance risks, and develop risk-mitigation plans.
- Lead quality initiatives including regulatory inspection preparation and ongoing inspection readiness activities.
- Support the review of CMC sections of regulatory submissions, including INDs and IMPDs, and contribute to responses to health authority questions related to manufacturing and quality.
Education and Experience:- BA/BS degree in Chemistry, Biology, or Life Sciences with at least 8 years of experience in the pharmaceutical industry
Essential Skills and Abilities:- Demonstrated knowledge of Quality Systems and cGMP within a regulated environment.
- Demonstrated knowledge of Good Distribution Practices.
- Auditing experience is required.
- Demonstrated experience providing quality oversight of CMOs, including audits, batch review, and issue resolution.
- Analytically strong with practical knowledge of how to identify key performance metrics and quality indicators to set targets and identify areas for improvement.
- Proven leadership, negotiation, and conflict management skills with experience influencing across functions and organizations
- Exceptional interpersonal skills with a focus on rapport-building, active listening, and effective questioning.
- Experience in environments requiring problem-solving and risk-based solutions.
- Excellent organizational and time management skills with a high level of attention to detail.
- Excellent verbal and written communication skills; ability to deal with complex problems, determine and evaluate risk, and present recommendations and findings in a clear, concise format.
- Experience in fast paced, start-up environments preferred - able to work comfortably under pressure, frequently changing landscape and tight deadlines.
