Manager, GMP Quality Assurance

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Ensure quality oversight throughout the CMC lifecycle management of Nuvalent’s products, covering areas such as Starting Materials, Drug Substance, Drug Product, or Finished Goods.

• Execute product release activities across all development phases, validation, and commercial production, which includes the review and approval of master batch records and executed batch records.

• Provide onsite oversight and monitoring of manufacturing campaigns as needed.

• Coordinate QP release as necessary.

• Engage effectively with external contract manufacturers and testing laboratories, while collaborating as part of an internal multidisciplinary team to conduct, review, and approve manufacturing, testing, and product complaint investigations.

• Assist in the preparation or review of CMC sections for regulatory submissions.

• Support related Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.

• Collaborate with the team to implement and maintain Quality Agreements with suppliers.

• Represent the QA department on Vendor project teams.

• Aid in conducting audits of CMOs and Testing Laboratories.

⛳️ Requirements

• Bachelor's degree in biology, chemistry, life sciences, or a related field preferred, or equivalent experience.

• Over 5 years of experience in Quality functions supporting cGMP manufacturing of pharmaceutical products.

• Required direct experience with GMP manufacturing of small molecule products.

• Additional direct experience with GMP manufacturing oversight of small molecule drug substances is advantageous.

• Preferred working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint, and Smartsheet.

• Strong understanding of cGMP regulations, practices, and trends related to pharmaceutical product development, manufacturing, testing, and clinical operations is required.

• Knowledge of cGMP regulations, practices, and trends related to commercial product manufacturing and testing is preferred.

• Willingness to travel approximately 15% of the time.

🏝️ Benefits

• Medical, dental, and vision insurance

• 401(k) retirement savings plan

• Generous paid time off, including a summer and winter company shutdown