Associate Director, Quality Control

The Role:

Reporting to the Associate Director, Analytical Sciences / Quality Control, the Associate Director, Quality Control will operate at both the strategic and execution levels, providing oversight of Nuvalent’s fully outsourced QC testing network, as well as QC leadership for an early-stage small molecule oncology program. The successful candidate needs to demonstrate a proven track record of working in a virtual drug development environment with CROs/CMOs in support of developing and delivering products for fast-paced clinical development programs. Using strategic thinking, strong analytical and QC experience, and a commanding knowledge of industry regulatory guidance, the candidate will support product development efforts through the review, tracking, and trending of product data, ensuring phase appropriate method validations, supporting of specification strategy, defining and managing stability programs, and strategic shelf-life planning.

The ability to thrive in a virtual environment in support of developing and delivering drug substance and drug product for fast-paced clinical development programs, and to coordinate commercial readiness deliverables will be critical. As the Quality Control subject matter expert for the program, 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 collaborate with the program’s Analytical, Drug Substance, Drug Product, Quality Assurance, CMC Project Management, and Regulatory CMC functional representatives. Responsibilities include ensuring that drug substance and drug product QC support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team. In addition, the role will ensure data generated on Nuvalent products are well documented, of high quality, appropriately and consistently reported, and aligned with the phase-appropriate strategy outlined by the project CMC Teams.

Responsibilities:

• 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. 

Competencies:

• 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.

Qualifications:

• 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.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

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.