Manager, CMC Quality

🕒 il y a 4 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 23%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Pulmovant

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Pulmovant est une entreprise dédiée à transformer la vie des patients atteints de maladies pulmonaires en développant des thérapies innovantes. Leur produit phare, le mosliciguat, vise à offrir un traitement inhalé quotidien pour l'hypertension pulmonaire, se distinguant par son mécanisme novateur d'activation de la sGC. Avec un objectif unique de répondre aux besoins spécifiques des patients souffrant de pathologies pulmonaires, Pulmovant s'engage dans des essais cliniques approfondis pour faire progresser ses options de traitement pionnières.

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

🎯 Exigences

• 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

🏖️ Avantages

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