Associate Director, Quality Control

Role Summary

Associate Director, Quality Control will operate at both strategic and execution levels, overseeing Nuvalent’s outsourced QC testing network and leading QC for an early-stage small molecule oncology program. The role requires a proven track record of virtual drug development with CROs/CMOs to support fast‑paced clinical programs. You will review, track, and trend product data, ensure phase‑appropriate method validations, support specification strategy, define stability programs, and plan shelf‑life.

The role also ensures compliance with GMP and GDP standards across global operations and collaborates with Analytical, Drug Substance, Drug Product, QA, CMC Project Management, and Regulatory CMC teams to deliver timely, high‑quality QC support and well‑documented data.

• Provide strategic leadership for commercial and clinical stability programs, ensuring global regulatory compliance and proactive risk management.
• Oversee quality control operations related to contract organizations (CROs/CMOs) to ensure robust quality systems and oversight into product disposition and release activities.
• Cross functional contribution to define, execute, and harmonize (as appropriate) QC strategies and best practices for Nuvalent development and commercial candidates
• Utilize stability trending and statistical analysis software (i.e. JMP) to monitor product performance, predict shelf‑life and QC support for investigations (OOS/OOT/OOE).
• Work with internal teams, CROs/CMOs to assemble data packages in support of shelf‑life extensions, specification and method changes, associated batch records, related data, and program life cycles.
• Oversee CDMOs for phase‑appropriate analytical method development, qualification, validation, and transfer for drug substance and drug product in‑process, release and stability testing. Review method development plan, qualification/validation protocols, test procedures, raw data, and technical reports and manage the activities to meet the project timelines.
• 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) 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.
• Support pre‑approval inspection and commercial readiness activities, internal, and external audits.

• 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.
• Ability to perform statistical manipulation of pharmaceutical product data to support specification and shelf‑life strategies
• 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.

• BS or equivalent in chemistry or related discipline with 10 – 15 years of relevant industry experience (or MS/PhD with 3 – 5 years of experience) with at least 3 of those years at the QC Senior Manager level or above.
• 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.
• Must thrive working in a fast‑paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Proven ability to lead, mentor, and develop QC staff while driving continuous improvement and phase‑appropriate analytical strategies. To influence cross functionally, and make clear, timely decisions.
• 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
• Strong knowledge 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 preferred.