Manager, GMP Quality Assurance

Nuvalent, Inc. • Cambridge, MA

1d

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the Senior Manager, GMP Quality Assurance, the Manager, GMP Quality Assurance is responsible for maintaining high levels of quality in Nuvalent drug substances, drug products, packaged drug products and finished goods by supporting contract manufacturing organizations (CMOs) and internal partners in Technical Operations.
Ensure Nuvalent and internal / external stakeholders comply with cGMPs and standards as well as regulations of applicable authorities.

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
• Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations is required.
• Ability to drive and deliver multiple projects within project scope and timelines.
• Proven ability to effectively communicate across all functions.

Nice To Haves

• 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.
• Knowledge of cGMP regulations, practices, and trends pertaining to commercial product manufacturing and testing is preferred.

Responsibilities

• 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.

Benefits

• Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees