Sr Director & Head of Product Quality Leaders (PQLs)

United States·San Rafaellead

Product ManagementOtherQualityProduct Director

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Quick Summary

Overview

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.

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.

Technical Tools

Product ManagementOtherQualityProduct Director

Responsibilities

~1 min read

→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.

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.

- 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

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.

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

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.

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.