Senior Director and Head of Product Quality Leaders

Title: Sr Director & Head of Product Quality Leaders (PQLs)

Location: San Rafael, California

Hybrid

Job Description:

Who We Are

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 (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

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

The Senior Director, Head of Product Quality Leaders (PQL) is responsible for leading a portfolio‑aligned Product Quality team that serves as Global Quality’s sole representation on TOPs Product Teams (TPT) and Value Stream Teams (VST) across the product lifecycle.  This role provides strategic and people leadership for PQLs and Device Quality, ensuring consistent, phase‑appropriate Quality input into CMC strategy, regulatory filings, and lifecycle decision‑making for clinical and commercial products. The organization supports a diverse pipeline and portfolio manufactured and tested through both internal and external networks.

Key Responsibilities

Lead the PQL & Device Quality Organization

• Lead, coach, and develop a team of PQLs and Device Quality Lead, establishing clear expectations, operating standards, and decision frameworks.
• Build a high‑credibility, technically strong organization capable of influencing CMC and device development decisions in complex, matrixed environments.
• Ensure consistent application of the PQL role across programs, phases, and modalities.

Define and Sustain the PQL Operating Model

• Establish and maintain a clear, repeatable PQL operating model that defines:

• • Scope and accountability as Quality’s sole representative on the TPT’s and VST’s
  • Decision rights, escalation pathways, and interfaces with other Quality sub‑functions
  • Phase‑appropriate expectations from pre‑IND through post‑approval lifecClick or tap here to enter text.cycle
  • Ensure alignment of PQL activities with company Quality policies, governance forums, and development/commercial strategies.

CMC Team Quality Leadership

• • Ensure PQLs effectively represent Quality on TPT’s and VST’s by:

• • Providing integrated Quality input into CMC strategy, development plans, and lifecycle decisions
  • Identifying, assessing, and communicating product‑specific quality risks within the CMC context
  • Enabling informed, risk‑based decision‑making grounded in product and process knowledge
  • Serve as the escalation point for complex or cross‑portfolio product quality issues arising within CMC teams 

Device & Combination Product Quality Leadership

• Set clear expectations for how Device Quality interfaces with the Device Development Teams and PQL’s.
• Support the Device Quality Head as needed on:

• • Portfolio‑level prioritization and resourcing
  • Alignment of device quality strategy with overall CMC and product lifecycle considerations
  • Escalation and resolution of complex, cross‑functional issues
  • Enable effective governance and visibility for device quality topics at the product and leadership level.

Regulatory CMC & Module 3 Accountability

• Oversee PQL ownership and authorship of key Quality‑related sections of Module 3 in:

• • INDs and amendments
  • BLAs / NDAs
  • Prior Approval Supplements (PAS) and other post‑approval submissions

• Ensure Quality positions in regulatory filings are:

• • Scientifically sound and phase‑appropriate
  • Internally consistent across submissions and lifecycle stages
  • Aligned with the product’s CMC strategy and control approach

Inspection Support & Subject‑Matter Participation

• Ensure PQLs and Device Quality leaders are prepared to support regulatory inspections as product and CMC subject‑matter experts.
• Provide context, historical rationale, and regulatory filing alignment when product‑specific questions arise.

Capability Building & Continuous Improvement

• Identify opportunities to improve consistency, efficiency, and clarity in how PQLs:
  • Evaluate and communicate product quality risk
  • Support regulatory submissions
  • Operate across modalities and lifecycle stages

• Drive standardization where appropriate (templates, guidance, best practices) without undermining scientific judgment or phase‑appropriate flexibility

Experience/Education

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

• 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in with multiple product modalities (e.g., small molecule, oligopeptides, biologics, etc.)
• Demonstrated experience leading product‑focused Quality roles embedded with CMC teams across clinical and commercial stages
• Strong experience with building and sustaining cross-functional relationships with key stakeholders (e.g., within Quality, TDS, Regulatory, etc.).  Highly capable of building strong, effective working teams; experience with developing relationships focused on best-practice sharing and collaborative problem solving
• Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment.  Excellent interpersonal and communications skill.
• Skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization
• In-depth understanding and application of cGMP principles, concepts, practices and standards; understanding of the international regulatory landscape preferred
• Strong working knowledge of Module 3 Quality expectations
• 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

Workstyle: 

• Hybrid requires being onsite in San Rafael, CA twice per week.  This role may not be performed virtually.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.