Head, Product Quality Leaders

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.

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 authorsh