Director, Product Quality Leader (PQL)
BioMarin Pharmaceutical Inc.
June 24, 2026
Remote friendly (United States)
United States
$176,000 - $239,000 USD yearly
Operations
Role Overview
- Serve as a technical quality expert for one or more products during clinical development through post-commercialization.
- Make technical quality-related decisions and act as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks, and issues for assigned products.
Key Responsibilities
- Single point of contact for product quality topics within the CMC team; provide technical quality expertise for global strategies and robust implementation plans (Pre-IND through post-Launch lifecycle management).
- Partner with the CMC team and Quality to develop and prioritize long-term product strategies/initiatives for clinical-to-commercial transition, new introductions, and tech transfers; create the product-specific Quality strategy.
- Lead the cross-functional Quality Partner Team (QPT) for Quality-related CMC deliverables; manage QPT timelines/scope and ensure clear communication to/from CMC and functional managers.
- Own and manage the product quality risk register (identify, resolve, mitigate, and/or escalate issues/risks).
- Develop phase-appropriate product specifications; establish and ensure implementation of the Quality Target Product Profile (QTPP).
- Develop product comparability protocols/assessments, including sample selection and acceptance criteria for process/site changes.
- Interpret and apply regulatory guidelines (e.g., 21 CFR, USP, EP, JP, ICH) to product quality; advise stakeholders on changes.
- Review/author regulatory submission sections; ensure clarity/consistency across Quality-owned content.
- Review/approve Annual Product Review for represented commercial programs.
- Oversee/monitor Health Authority CMC commitments and provide status updates.
- Support/lead initiatives to improve PQL operational efficiency/effectiveness and lead cross-portfolio improvements to reduce technical quality risks.
Experience/Education & Qualifications
- BA/BS in life sciences or related field (required); advanced degree desirable.
- 12+ years in highly regulated industry (biotechnology/pharma/medical device); preferred biologics product development/licensure or technical support; clinical-to-commercial experience highly desirable.
- Plus: experience with combination products across clinical/commercial stages (including device quality considerations).
- Periodic travel required.
Skills
- Strong interpersonal/communication skills across internal/external stakeholders.
- Demonstrated leadership; ability to balance speed, quality, and risk.
- Ability to influence in matrixed, cross-functional environments; build teams and collaborative problem-solving relationships.
- Ability to work with ambiguity/complexity; results-oriented and manage multiple projects.
- In-depth cGMP knowledge and understanding of international regulatory landscape (preferred).
- Broad Quality knowledge across biologic/chemical processes, drug development, and analytical methods; prior Regulatory/Quality/Compliance or related technical experience (analytical development, manufacturing sciences, Quality/Regulatory).
- Serve as a technical quality expert for one or more products during clinical development through post-commercialization.
- Make technical quality-related decisions and act as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks, and issues for assigned products.
Key Responsibilities
- Single point of contact for product quality topics within the CMC team; provide technical quality expertise for global strategies and robust implementation plans (Pre-IND through post-Launch lifecycle management).
- Partner with the CMC team and Quality to develop and prioritize long-term product strategies/initiatives for clinical-to-commercial transition, new introductions, and tech transfers; create the product-specific Quality strategy.
- Lead the cross-functional Quality Partner Team (QPT) for Quality-related CMC deliverables; manage QPT timelines/scope and ensure clear communication to/from CMC and functional managers.
- Own and manage the product quality risk register (identify, resolve, mitigate, and/or escalate issues/risks).
- Develop phase-appropriate product specifications; establish and ensure implementation of the Quality Target Product Profile (QTPP).
- Develop product comparability protocols/assessments, including sample selection and acceptance criteria for process/site changes.
- Interpret and apply regulatory guidelines (e.g., 21 CFR, USP, EP, JP, ICH) to product quality; advise stakeholders on changes.
- Review/author regulatory submission sections; ensure clarity/consistency across Quality-owned content.
- Review/approve Annual Product Review for represented commercial programs.
- Oversee/monitor Health Authority CMC commitments and provide status updates.
- Support/lead initiatives to improve PQL operational efficiency/effectiveness and lead cross-portfolio improvements to reduce technical quality risks.
Experience/Education & Qualifications
- BA/BS in life sciences or related field (required); advanced degree desirable.
- 12+ years in highly regulated industry (biotechnology/pharma/medical device); preferred biologics product development/licensure or technical support; clinical-to-commercial experience highly desirable.
- Plus: experience with combination products across clinical/commercial stages (including device quality considerations).
- Periodic travel required.
Skills
- Strong interpersonal/communication skills across internal/external stakeholders.
- Demonstrated leadership; ability to balance speed, quality, and risk.
- Ability to influence in matrixed, cross-functional environments; build teams and collaborative problem-solving relationships.
- Ability to work with ambiguity/complexity; results-oriented and manage multiple projects.
- In-depth cGMP knowledge and understanding of international regulatory landscape (preferred).
- Broad Quality knowledge across biologic/chemical processes, drug development, and analytical methods; prior Regulatory/Quality/Compliance or related technical experience (analytical development, manufacturing sciences, Quality/Regulatory).