Director, Product Quality Leader (PQL)

BioMarin Pharmaceutical Inc.

About The Position

BioMarin's Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market. This includes engineers, technicians, scientists, and support staff who build and maintain manufacturing processes and sites, ensure quality assurance and control to meet regulatory standards, procure necessary goods and services, and coordinate global drug distribution. The Director, Product Quality Leader (PQL) will serve as a technical quality expert for one or more products throughout their lifecycle, from clinical development to post-commercialization. This role is the primary point of contact for all quality functions, risks, and issues within the CMC (Chemistry, Manufacturing, and Controls) team, providing quality leadership for strategic activities and driving quality decisions.

Requirements

BA/BS in life sciences or related field required.
12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry.
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 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 and collaborative problem solving.
Skilled in the ability to work with ambiguity and complexity and can continuously modify 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.
Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods.
Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory.

Nice To Haves

Advanced degree desirable.
Preferred experience in biologics product development and licensure or technical support.
Experience in both clinical and commercial phases of product lifecycle is highly desirable.
Understanding of the international regulatory landscape preferred.

Responsibilities

Serve as the single point of contact within a CMC Team for all product quality topics, participating in meetings and technical forums to provide expertise and influence global strategies.
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 Quality organization to identify, develop, and prioritize long-term product strategies and initiatives for clinical to commercial transition, new product introductions, and tech transfers.
Accountable for the creation of the product-specific Quality strategy.
Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables.
Manage QPT deliverables in alignment with CMC execution plans, including timelines and scope.
Ensure timely and clear communication of 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.
Develop phase-appropriate product specifications as part of product control strategy creation.
Collaborate with the CMC Lead to establish a phase-appropriate Quality Target Product Profile (QTPP) and ensure the implementation of correct quality characteristics during product development.
Develop product comparability protocols and assessments for clinical-stage and commercial products, including sample selection and acceptance criteria identification for process/site changes.
Interpret and apply applicable regulatory guidelines and directives (e.g., 21CFR, USP, EP. JP, and ICH) to product quality.
Stay abreast of changes in regulatory guidelines and advise stakeholders appropriately.
Review and author regulatory submission sections and provide input for clarity and consistency.
Review and approve Annual Product Reviews 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 initiatives to improve the efficiency and effectiveness of PQL operational processes.
Identify and lead cross-portfolio initiatives or improvements to reduce overall technical quality risks for the product portfolio.