Associate Director, Product Quality Leader

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

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.Key Responsibilities 

• As the single point of contact within a CMC Team for all product quality topics, participate 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 for all stages of the product life cycle (Pre-IND through post-Launch lifecycle management)
• Partner with 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; accountable for managing the QPT deliverables in alignment with CMC execution plans, including timelines and scope. Responsible for timely and clear communication of all relevant information to and from the QPT to the CMC Team and functional managers
• Own and manage the product quality risk register to ensure identification, resolution, mitigation and/or escalation of product quality issues and risks to CMC team and/or Senior Management
• Responsible for developing a phase appropriate product specification as part of product control strategy creation; collaborate with CMC Lead to establish a phase appropriate Quality Target Product Profile (QTPP) and ensure the right quality characteristics are implemented during product development.
• Lead efforts to develop product comparability assessments for clinical-stage and commercial products, including sample selection and acceptance criteria identification needed to support process/site changes
• Interpret and apply applicable regulatory guidelines and directives (e.g., 21CFR, USP, EP. JP, and ICH) to product quality, staying abreast of changes and advising stakeholders appropriately
• Review and author regulatory submissions sections and provide input to ensure clarity and consistency of messaging across Quality owned sections
• Responsible for the review and approval of Annual Product Review for represented commercial programs
• Provide oversight and monitor CMC related Health Authority commitments and ensure timely completion. Provide 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

 Experience/Education

• BA/BS in life sciences or related field required. Advanced degree desirable.

• 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in gene therapy or biologics product development and licensure or technical support; experience in both clinical and commercial phases of product lifecycle a plus.
• Excellent interpersonal and communications 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 with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
• Highly capable of building strong, effective working teams; experience with developing relationships focused on best-practice sharing a