Director, CMC Quality

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 15%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• Provide quality oversight and direction to vendors to ensure drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with cGMPs • Ensure CMO and partner manufacturing operations comply with regulatory requirements and Pulmovant quality standards • Lead clinical lot disposition and batch record review • 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 • 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 • Review protocols, reports, test methods, specifications, master batch records, and SOPs • Partner with CMC, Supply Chain, and Regulatory Affairs to assess product quality, identify risks, and develop mitigation plans • Lead regulatory inspection preparation and ongoing inspection readiness activities • Support review of CMC sections of regulatory submissions, including INDs and IMPDs • Contribute to responses to health authority questions related to manufacturing and quality

🎯 Requirements

• BA/BS degree in Chemistry, Biology, or Life Sciences • At least 8 years of experience in the pharmaceutical industry • Demonstrated knowledge of Quality Systems and cGMP within a regulated environment • Demonstrated knowledge of Good Distribution Practices • Auditing experience required • Experience providing quality oversight of CMOs, including audits, batch review, and issue resolution • Practical knowledge of performance metrics and quality indicators • Leadership, negotiation, and conflict management skills • Experience influencing across functions and organizations • Strong interpersonal skills, rapport-building, active listening, and effective questioning • Experience with problem-solving and risk-based solutions • Excellent organizational and time management skills with attention to detail • Excellent verbal and written communication skills • Ability to evaluate risk and present recommendations and findings clearly and concisely • Experience in fast-paced, start-up environments preferred • Ability to work under pressure, adapt to a frequently changing landscape, and meet tight deadlines

🏖️ Benefits

• Equal employment opportunities and protection from discrimination and harassment • Individual contributor role within a lean QA team • Collaboration and innovation as part of the Roivant family of companies