Manager, GMP Quality Assurance

Role Overview

• 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 and approval of master batch records and executed batch records.
• Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.
• Coordinate QP release as appropriate.
• Effectively interact with external contract manufacturers, testing laboratories, and work as part of an internal multidisciplinary team to conduct, review, and approve manufacturing, testing, and product complaint investigations.
• Assist in preparing or reviewing CMC sections of regulatory submissions.
• Supports associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
• Work with team to implement/maintain Quality Agreements with suppliers.
• Represent the QA department on Vendor project teams.
• Assist in conducting audits of CMOs and Testing Laboratories.

Requirements

• Bachelor’s degree in biology, chemistry, life sciences field preferred or related experience.
• 5+ years of experience working in Quality functions supporting cGMP manufacturing of pharmaceutical products.
• Direct experience working with the GMP manufacturing of small molecule products is required
• Direct experience working with the GMP manufacturing oversight of small molecule drug substances is a plus
• Working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint and Smartsheet is preferred.
• Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations is required.
• Knowledge of cGMP regulations, practices, and trends pertaining to commercial product manufacturing and testing is preferred.
• Travel approximately 15%

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off (including a summer and winter company shutdown)