Manager, CMC Quality

🔥 16 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Support quality oversight of vendors to ensure drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with cGMPs • Lead batch record review and clinical lot disposition for drug substance, inhaled drug product, and clinical packaging and labeling • Support QP certification and release activities at contract manufacturing partners for ex-US clinical trials • Prepare batch documentation packages and coordinate release timelines with CMOs, Supply Chain, and Clinical Operations • Review executed batch records, certificates of analysis, and testing data for accuracy, completeness, and conformance • Drive resolution of documentation errors and gaps • Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations • Maintain disposition and batch review tracking and metrics • Communicate product quality performance and release status to Quality and cross-functional teams • Partner with CMC, Supply Chain, and Regulatory Affairs on product quality impacts, risks, and mitigation plans • Review and provide quality input on batch records, specifications, test methods, protocols, reports, and SOPs • Support batch release and disposition procedures • Support regulatory inspection preparation and inspection readiness activities

🎯 Requirements

• BA/BS degree in Chemistry, Biology, or Life Sciences • At least 4 years of experience in the pharmaceutical industry, including GMP quality assurance experience • 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 ex-US clinical supply requirements, including EU Annex 13 and 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 ability to apply risk-based decision making • Strong interpersonal skills and 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 • Experience in fast-paced, start-up environments preferred • Ability to work under pressure amid changing priorities and tight deadlines

🏖️ Benefits

• Equal employment opportunities and nondiscrimination protections • No unsolicited resumes or agency outreach accepted