Manager, GMP Quality Assurance
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $125,000 - $145,000 per year
About the role
- 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
- 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
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality oversightCMC lifecycle managementproduct release activitiesmaster batch recordsexecuted batch recordsGMP manufacturingregulatory submissionsauditsCAPAsChange Controls
Soft Skills
effective interactionteam collaborationmultidisciplinary teamworkcommunicationoversightmonitoring