Senior Manager, Quality Control

Summary

Join Nuvalent, a dynamic early-stage company focused on developing selective cancer medicines, as their Senior Manager, Quality Control. Reporting to the Associate Director, Analytical Sciences/QC, you will lead QC activities for a late-stage oncology program. This role demands expertise in working with CROs/CMOs for testing and documentation review, ensuring GMP and GDP compliance. You will collaborate with various internal teams and external partners, ensuring timely and high-quality QC support. Success requires a proven track record in QC management within the pharmaceutical industry and a strong understanding of relevant regulations.

Requirements

• BS or equivalent in chemistry or related discipline with a minimum of eight (8) years of relevant industry experience (or MS/PhD with 5+ years’ experience) with at least 2 of those years at the QC Manager level
• A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical drug substance and drug product development and manufacturing is required
• Knowledge of analytical testing concepts in small-molecule Drug Substance and Drug Product including laboratory controls and good documentation practices
• Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections
• Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations
• Good understanding of product process and development, from discovery to commercialization
• Knowledgeable in CGMP regulations and ICH or other industry guidance
• Proven track record solving analytical and QC challenges with a focus on small molecules

Responsibilities

• Work with internal teams, CMOs, and Test Labs to assemble data packages in support of shelf-life extensions, specification and method changes, associated batch records, related data, and program life cycles
• Cross-functional contribution to derive and implement the best QC practice for a late-phase program
• QC review of analytical release and stability data for completeness, accuracy, consistency with specifications and/or protocol design as applicable
• QC review of method development, method validation, method transfer, and regulatory source documents
• Tabulate, assessment, and archival of stability testing data as part of product and method life cycle management. Identify trends and ensure data is analyzed to help understand degradation pathways in aid of product life cycle
• Investigate and resolve analytical test failures (OOS and atypical results) with support of a cross-functional team
• Collaborate closely with the functional teams to support the synthesis, certification, release, and management of associated reference material
• Author and/or review QC sections (e.g., batch analysis, analytical methods, reference standard, etc.) of regulatory submission documents, as well as author and review relevant change controls and SOPs
• Contribute to appropriate sections of CMC sections for submission as well as Annual Product Reviews
• Participate in vendor and internal audits as needed

Preferred Qualifications

Proficiency with JMP and application of statistical analysis concepts is preferred