Director, Product Quality Leader

Product Quality Leader (PQL) Role Overview

This individual will serve as a technical quality expert for one or more products during clinical development all the way through post‑commercialization. The role is responsible for making technical quality‑related decisions and serving as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks and issues associated with the assigned products. As a core member of the CMC team, the PQL provides efficient and effective quality leadership of CMC‑related strategic activities and drives associated quality decisions.

• Serve as the single point of contact within a CMC Team for all product quality topics, participating fully in CMC team meetings and other relevant technical forums, providing technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes throughout the product life cycle (Pre‑IND through post‑Launch lifecycle management).
• Partner with the CMC Team and the Quality organization to identify, develop and prioritize long‑term product strategies/initiatives enabling the clinical to commercial transition, new product introductions and tech transfers; accountable for creation of the product‑specific Quality strategy.
• Lead the cross‑functional Quality Partner Team (QPT) supporting Quality‑related CMC deliverables; manage the QPT deliverables in alignment with CMC execution plans, including timelines and scope, and communicate all relevant information to and from the QPT and functional managers.
• Own and manage the product quality risk register to ensure identification, resolution, mitigation and escalation of product quality issues and risks to the CMC team and senior management.
• Develop phase‑appropriate product specifications as part of the product control strategy; collaborate with the CMC Lead to establish a phase‑appropriate Quality Target Product Profile (QTPP) and ensure the right quality characteristics are implemented during product development.
• Develop product comparability protocols and assessments for clinical‑stage and commercial products, including sample selection and acceptance criteria identification to support process/site changes.
• Interpret and apply applicable regulatory guidelines and directives (e.g., 21
  
  CFR, USP, EP, JP and ICH) to product quality, staying abreast of changes and advising stakeholders appropriately.
• Review and author regulatory submission sections and provide input to ensure clarity and consistency of messaging across Quality‑owned sections.
• Review and approve Annual Product Review for represented commercial programs.
• Oversee and monitor CMC‑related Health Authority commitments and ensure timely completion, providing routine updates and visibility of submission commitments to functional and senior management.
• Support or lead efforts to identify, define, and mobilize initiatives to improve the efficiency and effectiveness of PQL operational processes.
• Identify and lead cross‑portfolio initiatives or improvements that will reduce overall technical quality risks for the product portfolio, as required.

• BA/BS in life sciences or related field required. Advanced degree desirable.
• 12+ years of experience in a highly regulated industry such as biotechnology, pharmaceutical, medical device or other; preferred experience in biologics product development and licensure or technical support; experience in both clinical and commercial phases of the product lifecycle is highly desirable.
• Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus.
• Excellent interpersonal and communication skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Demonstrated strong leadership capability with ability to align on, make and act on decisions while balancing speed, quality and risk.
• Experience influencing diverse stakeholders and driving accountability and decision‑making in a highly matrixed, cross‑functional environment.
• Highly capable of…