Manager, GMP Quality Assurance

1w1 week ago

Nuvalent

Cambridge, US · Full-time · $125,000 – $145,000

About this role

With deep expertise in chemistry, Nuvalent creates selective medicines to address cancer patient needs. This early-stage company unites experienced scientists and industry veterans in drug discovery, oncology development, and company building. The Manager, GMP Quality Assurance reports to the Senior Manager, maintaining high quality in drug substances, products, and finished goods.

Provide quality oversight throughout the CMC lifecycle for starting materials, drug substance, drug product, or finished goods. Conduct product release activities across development, validation, and commercial production by reviewing batch records. Ensure compliance with cGMPs and regulations for Nuvalent and stakeholders.

Interact with contract manufacturing organizations, testing laboratories, and internal multidisciplinary teams for manufacturing reviews and investigations. Represent QA on vendor project teams and implement quality agreements with suppliers. Assist in audits of CMOs and testing labs while providing onsite manufacturing oversight.

Support investigations, CAPAs, change controls, and OOS processes. Coordinate QP release and prepare CMC sections for regulatory submissions. Join a dynamic team driving innovative cancer therapies with approximately 15% travel.

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 required
Direct experience working with the GMP manufacturing oversight of small molecule drug substances preferred
Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations required
Knowledge of cGMP regulations, practices, and trends pertaining to commercial product manufacturing and testing preferred
Working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint and Smartsheet preferred
Travel approximately 15%

Responsibilities

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 and monitoring of manufacturing campaigns
Coordinate QP release as appropriate
Interact with external contract manufacturers, testing laboratories, and internal teams for investigations
Assist in preparing or reviewing CMC sections of regulatory submissions
Support associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS
Work with team to implement and maintain Quality Agreements with suppliers

Benefits

Committed to fair and equitable compensation practices
Competitive total rewards packages
Comprehensive benefit package to support employees at each stage of their career