Manager, GMP Quality Assurance

Manager, GMP Quality Assurance 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.

Requirements

• Provide quality oversight throughout the CMC lifecycle management of Nuvalent's products.
• Conduct product release activities for all phases of development, validation, and commercial production.
• 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.

Benefits

• Comprehensive benefit package including medical, dental, and vision insurance
• 401(k) retirement savings plan
• Generous paid time off (including a summer and winter company shutdown)
• Summer and winter company shutdown