Manager, Quality Control

The Role:

Reporting to the Director of Quality Control, the Manager, Quality Control will be responsible for managing the analytical Reference Material & Reference Standards (RMRS) program at Nuvalent. The candidate will ensure the program is in compliance with Nuvalent policies, standards, procedures and global cGxP to support clinical and commercial operations. In addition, this role will provide leadership of reference material lifecycle management, qualification/re-qualification of RMRS, change management and continuous improvements in the Analytical/QC group and Technical Operations Department.

The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs, and to coordinate commercial readiness deliverables will be critical. As the Quality Control expert, the candidate is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality Control department performs to a standard that ensures the quality of products and materials produced by our contracted partners. 

The candidate will interface with the program CMC Cross-functional representatives to ensure that RMRS QC support is timely, high quality, and consistent with the Phase-Appropriate strategies outlined by the project team and CMC Team.

Responsibilities:

• Collaborate closely with the functional teams to support the synthesis, certification, release, and management of associated reference material.
• Manage the RMRS material inventory database.
• Work with internal teams, CMOs, and Test Labs to assemble data packages in support of RMRS management.
• QC review of RMRS analytical data for completeness, accuracy, consistency with specifications and/or protocol design as applicable.
• Tabulate, assess, and archival of qualification/re-qualification testing data to help understand degradation pathways in aid of product life cycle.
• Support the qualification and management of GxP vendors for RMRS synthesis and related analytical work as applicable.
• Investigate and resolve analytical test failures (OOS and atypical results) with support of cross-functional team.
• Author and/or review relevant sections of regulatory submission documents, as well as author and review relevant change controls and SOPs.

 Competencies Include:

• Excellent organization and multi-tasking skills and ability to drive and deliver multiple projects within project scope and timelines.
• Ability to think critically with strong attention to detail.
• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
• Clear professional communication and presentation skills.

 Qualifications:

• Bachelor’s degree or equivalent in chemistry or related discipline with 4+ years of relevant industry experience with at least 2 of those years at the QC Manager level.
• Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations.
• Knowledgeable in CGMP regulations and ICH or other industry guidance.
• Proven track record solving analytical and QC challenges with a focus on small molecules.
• Proficiency with JMP and application of statistical analysis concepts is strongly preferred.
• Prior stability program management experience is a plus.