BioMarin Pharmaceutical Inc. · 1 month ago
Director, Product Quality Leader
Novato, CA
Full-time
Onsite
Director/Executive
12+ years expBioMarin Pharmaceutical Inc. is a global biotechnology company focused on translating genetic discoveries into new medicines. The Director, Product Quality Leader will serve as a technical quality expert for products during clinical development and post-commercialization, responsible for quality-related decisions and leading cross-functional quality initiatives.
BiotechnologyDeveloper PlatformPharmaceutical
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
Responsible for developing 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
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
Qualification
Required
BA/BS in life sciences or related field required
12+ years of experience with 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 product lifecycle is highly desirable
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; understanding of the international regulatory landscape preferred
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
Preferred
Advanced degree desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Company
BioMarin Pharmaceutical Inc.
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery.
1001-5000 employees
H1B Sponsorship
BioMarin Pharmaceutical Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (23)
2023 (24)
2022 (26)
2021 (24)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$585.8M2020-05-11Post Ipo Debt· $585.8M
1999-07-26IPO
Leadership Team
Brian Mueller
Chief Financial Officer
Arpit Davé
Executive Vice President, Chief Digital and Information Officer
Recent News
2026-01-13
Morningstar.com
2026-01-09
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