Director, Product Quality Leader

BioMarin Pharmaceutical Inc.; United States; On-site; USD 130,000 - 170,000; Full time

Job summary

An innovative biotechnology firm is seeking a Director, Product Quality Leader to act as a technical quality expert during clinical and post-commercialization phases. The successful candidate will manage product quality risks, develop specifications, and lead a Quality Partner Team to ensure compliance with regulatory standards. With over 12 years of experience in a highly regulated industry, the director will play a crucial role in enhancing product quality and driving strategic initiatives within the organization.

Qualifications

• 12+ years of experience in a highly regulated industry.
• Experience in biologics product development and licensure.
• Excellent written and verbal communication skills.

Responsibilities

• Act as the single point of contact for product quality topics.
• Lead the cross-functional Quality Partner Team.
• Develop phase-appropriate product specifications.

Skills

Excellent interpersonal and communication skills

Strong leadership capability

Ability to work with ambiguity

Results oriented

Knowledge of cGMP principles

Education

BA/BS in life sciences or related field

Advanced degree

Job description

Director, Product Quality Leader

BioMarin Pharmaceutical Inc.

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.

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 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 Product Quality Leader (PQL) will serve as a technical quality expert for one or more products during clinical development all the way through post‑commercialization. The role is responsible for making technical quality‑related decisions and serving as the single point of contact on the CMC team for all quality functions, risks and issues associated with the assigned products.

Key Responsibilities

• Act as the single point of contact within a CMC Team for all product quality topics, participating fully in CMC team meetings and other relevant technical forums, providing technical quality expertise to influence global strategies and ensuring robust implementation plans for product/program changes for all stages of the product life cycle (Pre‑IND through post‑Launch lifecycle management).
• Partner with the 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 the 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 the CMC team and/or senior management.
• Develop phase‑appropriate product specifications as part of product control strategy creation; collaborate with the CMC Lead to establish a phase‑appropriate Quality Target Product Profile (QTPP) and ensure the right quality characteristics are implemented during product development.
• Develop 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 submission sections and provide input to ensure clarity and consistency of messaging across quality‑owned sections.
• Review and approve the 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.

Experience and Education

• BA/BS in life sciences or related field required. Advanced degree desirable.
• 12+ years of experience in a highly regulated industry such as biotechnology, pharmaceutical, or medical device; preferred experience in biologics product development and licensure or technical support; experience in both clinical and commercial phases of the product lifecycle is highly desirable.
• Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus.
• Excellent interpersonal and communication 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 the ability to align on, make and act on decisions while balancing speed, quality, and risk.
• Experience 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; 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.

Travel expected: 15‑20%.

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.

Senior Level

Director

Employment Type

Full‑time

Job Function

Management, Product Management, and Quality Assurance

Industries

Biotechnology Research and Pharmaceutical Manufacturing