Senior Manager, GMP Quality Assurance

Summary

Join Nuvalent, a leading biopharmaceutical company focused on developing innovative cancer treatments, as a Senior Manager, GMP QA. Reporting to the Director, GMP QA, you will play a critical role in ensuring the highest quality standards throughout the lifecycle of our drug products. This position requires a strong understanding of cGMP regulations and extensive experience in quality assurance within pharmaceutical manufacturing. You will provide quality oversight, conduct product disposition activities, and collaborate with internal and external stakeholders to maintain compliance. The role involves significant interaction with contract manufacturers and testing laboratories, as well as participation in regulatory submissions. This is an excellent opportunity to contribute to the development of life-saving medicines in a dynamic and growing company.

Requirements

• Ability to drive and deliver multiple projects within project scope and timelines
• Proven ability to effectively communicate across all functions
• Bachelor’s degree in biology, chemistry, life sciences field preferred or related experience
• 7+ years of experience working in Quality functions supporting cGMP manufacturing of pharmaceutical products
• Small molecule experience required
• Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations is required
• Travel approximately 15% (international & domestic)

Responsibilities

• Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products with a primary focus on small molecule drug product operations including review and approval of GMP protocols and reports
• Participates in risk assessment for design, process and product FMEAs
• Conduct product disposition activities for all phases of development including review and approval of master batch records and executed batch records
• Provide onsite oversight/monitoring of manufacturing campaigns as appropriate
• Assist in the Development, Review and approval Annual Product Reviews (Vendor and Internal)
• 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

Preferred Qualifications

• Experience supporting drug product validation and commercial manufacturing preferred
• Working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint and Smartsheet is preferred