Key Facts

Remote From:

United States

Full time

Expert & Leadership (>10 years)

English

Hard Skills

Other Skills

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People Management
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Transformational Leadership
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Decision Making
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Communication
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Strategic Planning
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Executive Presence
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Problem Solving

BioMarin Pharmaceutical Inc.

Research

About BioMarin Pharmaceutical Inc.

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact. Recruitment Fraud Alert Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral. In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity. If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit. We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.

Company type: Large

Industry: Research

Founded: 2018

Company size: 1001 - 5000

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Job description

Description

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

SUMMARY DESCRIPTION

The Director, Global Supplier Quality Management is a senior leadership role with enterprise-wide authority and accountability for the governance, effectiveness, and continuous advancement of BioMarin’s global Supplier Quality Management framework across the external supply network for GMP/GDP materials. This role serves as the quality authority for suppliers and materials, ensuring sustained regulatory compliance, product quality, and patient safety while enabling uninterrupted and scalable business operations.

The Director defines and drives the global Supplier Quality vision and strategy and exercises decision-making authority across the full supplier lifecycle, in close partnership with Procurement and Technical Operations. This includes supplier qualification, raw material specification oversight, quality agreements, supplier changes, deviations, performance management, auditing, and inspection readiness. The role interfaces at the enterprise level with senior leaders across Quality, Technical Operations, Manufacturing, Legal and Procurement to prevent quality risk, improve supplier capability, and embed a consistent, risk-based approach across the global network.

As a key change leader within Quality, the Director is also accountable for advancing digital and data-enabled Supplier Quality capabilities, including the adoption of automation, advanced analytics, and artificial intelligence (AI). Through these capabilities, the role ensures proactive risk identification, data-driven decision-making, and scalable oversight aligned with BioMarin’s long-term business and quality strategy.

This position requires deep GxP expertise, strong executive presence, and the ability to operate with authority and influence in a complex, global, matrixed organization.

RESPONSIBILITIES:

Global Supplier Quality Strategy & Governance

Establish and maintain a risk-based, fit-for-purpose Global Supplier Quality Management framework aligned with BioMarin’s Global Quality Management System (QMS) and global regulatory requirements.
Define and execute the global Supplier Quality strategy to ensure consistent oversight, compliance, inspection readiness, and continuous improvement across the external supply network.
Jointly with Procurement, hold end-to-end ownership of the Supplier Lifecycle Management program, spanning supplier selection, qualification, onboarding, performance management, change management, and lifecycle exit decisions.
Own and oversee Supplier Quality core processes, including supplier qualification and lifecycle management, quality agreements, supplier changes, deviations, CAPA, and supplier auditing activities related to external suppliers.
Develop and maintain governance models, metrics, and management review processes to monitor Supplier Quality performance and escalate compliance risks appropriately.

Supplier Oversight, Risk Management & Performance Improvement

Ensure quality oversight of external suppliers, with a primary focus on materials and services supporting Technical Operations.
Provide Quality oversight for raw material specification management, ensuring specifications are scientifically sound, compliant, and aligned with manufacturing and control strategies.
Develop, define, and apply risk-based supplier oversight and segmentation models to focus resources on critical suppliers and material risks.
Establish and manage key Supplier Quality performance indicators, ensuring trending, signal detection, and timely actions.
Lead supplier quality issue investigations, risk assessments, and mitigation strategies to prevent non-conformances from impacting BioMarin operations or patients.
Collaborate with Procurement and Suppliers to drive quality improvement initiatives and enhance supplier capability, robustness, and compliance.

Auditing & Inspection Readiness

Establish, manage, and continuously improve the global Supplier Auditing program for all GMP and GDP suppliers, including audit strategy, planning, execution, follow-up, and effectiveness verification.
Ensure supplier audit outcomes, identified risks, and corrective actions are appropriately evaluated, trended, and integrated into Supplier Lifecycle Management and Quality Management Review processes.
Support and represent Supplier Quality during regulatory inspections and external audits involving suppliers and the external supply network.

Digital Transformation, Data & Artificial Intelligence

Lead the digital advancement of Supplier Quality by defining and executing a Supplier Quality technology and data roadmap aligned with the broader Quality Digital Strategy.
Leverage advanced analytics, automation, and AI-enabled solutions to improve supplier performance monitoring, risk identification, trend analysis, audit effectiveness, and decision-making.
Drive effective use of Supplier Quality data by integrating information from QMS, ERP, and external systems to generate actionable insights across the supplier lifecycle.
Partner with IT, Quality Systems, and business stakeholders to implement sustainable, scalable digital and AI solutions that enhance Supplier Quality effectiveness and efficiency.

Cross-Functional & Network Collaboration

Partner closely with Global Procurement, Manufacturing, Technical Development and other key stakeholders to ensure supplier requirements are clearly defined, aligned with business needs, and embedded across the supplier lifecycle.
Collaborate with cross-functional teams to ensure documentation supporting sourcing decisions, supplier selection, raw material specifications, and material suitability is robust, compliant, and fit for purpose.
Represent Supplier Quality in cross-functional governance forums and during regulatory inspections and audits.

Leadership, Talent & Organization Development

Lead, coach, and develop a high-performing global Supplier Quality team across multiple geographies.
Establish clear roles, responsibilities, capabilities, and succession plans within the Supplier Quality organization.
Drive a consistent, standardized approach to Supplier Quality and supplier lifecycle governance across the global network while enabling flexibility where required.
Foster a culture of quality, continuous improvement, innovation, and accountability within the team.
Lead talent acquisition, onboarding, performance management, and career development initiatives.

Financial & Business Management

Develop, manage, and monitor budgets and long-range plans for the Global Supplier Quality function.
Ensure appropriate resourcing and capabilities are in place to meet growing business, compliance, supplier oversight, and digital transformation needs.

EDUCATION:

Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
Advanced degree (MS, PhD, MBA) desirable but not required.
Six Sigma or Lean certification desirable.

EXPERIENCE:

Minimum of 15 years of experience in Quality Assurance, Supplier Quality, Manufacturing, or related roles within a highly regulated industry (biotechnology, pharmaceutical, medical device, or combination products).
In-depth knowledge of global quality and regulatory requirements (e.g., GMP, GCP, GDP, ISO standards, 21 CFR).
Demonstrated experience leading global supplier quality programs and managing complex external supply networks.
Proven leadership experience with the ability to develop, mentor, and inspire high-performing teams.
Strong experience operating in a matrix, global environment and influencing without direct authority.
Experience leading or sponsoring transformational change, including digital transformation initiatives.
Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions a strong plus.
Excellent communication, collaboration, and stakeholder management skills, including interaction with senior leadership and regulators.

WORKSTYLE:

This role may be performed remotely. However if you live within 100 miles of Novato, CA (zip 94903) the role reverts to hybrid requiring an onsite presence 2x each week

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.

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.