Manager, GMP Quality Assurance

Nuvalent, Inc.

Manager, GMP Quality Assurance overseeing quality throughout CMC lifecycle at pharmaceutical company. Ensuring compliance with cGMPs and regulations while supporting contract manufacturers and internal partners.

Posted 5/11/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $125,000 - $145,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality oversightCMC lifecycle managementproduct release activitiesmaster batch recordsexecuted batch recordsauditsCAPAsChange ControlsOOSGMP manufacturing

Soft Skills

effective interactionteam collaborationoversight/monitoringcoordinationcommunication