Manager, GMP Quality Assurance

Job description

The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Manager, GMP Quality Assurance, the Manager, GMP Quality Assurance is responsible for maintaining high levels of quality in Nuvalent drug substances, drug products, packaged drug products and finished goods by supporting contract manufacturing organizations (CMOs) and internal partners in Technical Operations. Ensure Nuvalent and internal / external stakeholders comply with cGMPs and standards as well as regulations of applicable authorities. Responsibilities: Competencies: Qualifications: - Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products. Areas may include Starting Materials, Drug Substance, Drug Product or Finished Goods. - Conduct product release activities for all phases of development, validation, and commercial production including review a...