Senior Manager, GMP Quality Assurance

The Role:
Reporting to the Director, GMP QA, the Senior Manager, GMP QA role 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 GMPs and standards as well as regulations of applicable authorities.

Responsibilities:
•    Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products with a primary focus on small molecule drug product 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.

 Competencies:
•    Ability to drive and deliver multiple projects within project scope and timelines.
•    Proven ability to effectively communicate across all functions.

Qualifications: 
•    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. 
•    Small molecule experience required
•    Experience supporting drug product validation and commercial manufacturing 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.
•    Travel approximately 15% (international & domestic)