Director, Product Quality Leader (PQL)

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia, PKU (phenylketonuria), CLN2 (a form of Batten disease), and multiple forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few options. With the recent acquisition of Amicus, our portfolio now includes therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

BioMarin’s Technical Operations group is responsible for creating our drugs for clinical trials and scaling production for the commercial market. This team of engineers, technicians, scientists, and support staff builds and maintains cutting-edge manufacturing processes, ensures quality assurance and regulatory compliance, and coordinates the global distribution of our therapies.

About the role

This individual will serve as a technical quality expert for one or more products during clinical development 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 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.

Responsibilities

• Serve as the single point of contact within a CMC Team for all product quality topics; participate 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 across all stages of 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; accountable for managing 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 the CMC team and/or Senior Management.
• Develop 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.
• Develop product comparability protocols and 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.
• Review and approve 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.

Requirements

• BA/BS in life sciences or related field required; advanced degree desirable.
• 12+ years of experience in Biotechnology, Pharmaceutical, Medical Device, or other highly regulated industry; 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 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 the 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 building strong, effective working teams; experience developing relationships focused on best-practice sharing and collaborative problem-solving.
• Skilled in working with ambiguity and complexity and continuously modifying options and solutions across all levels of the organization. Results-oriented; effectively manages multiple projects efficiently.
• Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker.
• In-depth understanding and application of cGMP principles, concepts, practices, and standards; understanding of the international regulatory landscape preferred.
• Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, and analytical methods.
• Prior experience with Regulatory, Quality, Compliance, or a combination of technical experience such as analytical development, manufacturing sciences, and Quality/Regulatory.
• Periodic travel is required.