Remote Senior Manager, Quality Assurance

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients as a Senior Manager, GMP QA. This role is responsible for maintaining high quality in Nuvalent drug substances and products by supporting contract manufacturing organizations (CMOs) and internal partners.

Requirements

• 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
• Commercial and packaging validation experience required
• Direct experience working on artwork development, serialization and product launch preferred
• 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

Responsibilities

• Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products with a primary focus on packaging, labeling and serialization 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