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Associate Director, GMP/GLP Quality Assurance

Company: Nuvalent
Location: Cambridge
Posted on: February 19, 2021

Job Description:

Associate Director, GMP/GLP Quality AssuranceUS-MA-CambridgeJob ID: 2021-1401Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentNuvalentOverviewAssociate Director, GMP/GLP Quality Assurance With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management. Job Summary:The Associate Director (AD), Quality Assurance will be an integral part of a highly productive development team overseeing GMP and GLP activities across a global network of contract organizations. The successful candidate will be primarily responsible for GMP/GLP quality oversight of external CROs/CMOs including disposition of GMP manufactured products and clinical trial materials, leading Nuvalent's vendor qualification program, and providing QA support of GLP activities where required. This Quality Assurance professional will be a key leader in the Nuvalent quality organization. We are looking for someone who can work cross functionally to provide phase appropriate QA oversight and ensure Nuvalent's Quality practices remain compliant with regulations and commensurate with the phase and speed of a rapidly developing portfolio. This position will report to the VP of Pharmaceutical Development and have further opportunity to:ResponsibilitiesOpportunity and Responsibilities:

Collaborate with a team that sets strategies and oversees drug substance and drug product process design, optimization, scale-up, and manufacturing in support of early phase clinical development Define policies and procedures as a part of building an effective organization that can govern quality oversight of external contract manufacturingOversee Nuvalent quality systems as they relate to GMP/GLP activities and ensure SOPs and document archival are up to date Lead the disposition of investigational medical products in accordance with cGMPs, standards, and regulations of applicable authoritiesHelp manage and select the network of contract research and manufacturing organizations utilized by NuvalentDirect independent external quality resources to work as a seamless part of the Nuvalent team QualificationsMinimum Requirements
Bachelor's degree and 10+ years of relevant industrial experience in an innovator company supporting early phase drug development with at least 5 years in a Quality roleKnowledge and understanding of current ICH guidelines, GLP/GMP guidelines, and related industry practicesProven experience related to risk management principles, processes, and best practicesExcellent scientific and business communication skills (verbal, written and technical), possess ability to work in a matrix environment, strong interpersonal/collaboration skills and planning skillsAbility to think critically, work independently, and can determine appropriate resources to overcome challengesNuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18#LI-DNI PI129922099

Keywords: Nuvalent, Cambridge , Associate Director, GMP/GLP Quality Assurance, Executive , Cambridge, Massachusetts

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