Director Risk, Compliance & Traceability

Who We Are

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. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

JOB DESCRIPTION

Job Title: Director Risk, Compliance & Traceability
Department / Cost Centre: Global Supply Chain, SC Strategy & Excellence
(TBD) 601
Reports to (Job Title): Head Supply Chain Strategy & Excellence
Location: Onsite / Remote, US / EU
Full-Time Part-Time Regular Temporary Exempt Non-Exempt

SUMMARY DESCRIPTION
The Director, Risk, Compliance & Traceability reporting to the Supply Chain Strategy
organization will be responsible for developing, implementing and managing programs that
ensure product integrity, traceability, and compliance across the end-to-end supply chain.
The Director drives key initiatives involving serialization, cold chain compliance, and risk
management, partnering across functions to ensure compliant and efficient distribution of
BioMarin's products. This position also oversees cold chain technology and
innovation, influencing product design and ensuring temperature-sensitive products are
distributed in full compliance with Good Distribution Practice (GDP)

RESPONSIBILITIES

Strategic Leadership & Risk Management
* Provide strategic direction for risk, compliance, and traceability across the
global supply chain.
* Develop and lead a holistic risk management framework integrating
geopolitical, operational, compliance, and cybersecurity risks.
* Lead risk maturity assessments, stress testing, and the deployment of
predictive analytics and AI/ML tools for early warning and real-time
monitoring.
* Advise executive leadership on emerging trends, risk metrics, and strategic
recommendations.
Cold Chain Technology Management, Compliance & Innovation
* Oversee the design, qualification, and continuous improvement of cold chain
systems and packaging for temperature-sensitive products.
* Drive innovation in cold chain technologies, including advanced monitoring
systems, digital data analytics, and next-generation packaging solutions.
* Ensure global compliance with GDP and other regulatory requirements (EU
GDP, FDA, WHO, DSCSA, EU FMD, ANVISA, etc.).
* Develop and maintain policies, procedures, and training programs related to
GDP, compliance, and supply chain integrity
* Serve as the primary point of contact for audits and inspections related to cold
chain, and traceability.
Product Security & Traceability
* Lead the design, implementation, and continuous improvement of serialization
and traceability programs.
* Build and manage a digital control tower for end-to-end product traceability,
integrating data from manufacturing, packaging, logistics, and distribution.
* Evaluate and implement emerging technologies like blockchain to enhance
transparency and trust.
* Develop and oversee a comprehensive product security framework to detect,
deter, and respond to threats such as counterfeiting, diversion, and tampering
Cross-Functional Collaboration & Vendor Management
* Collaborate with Global Supply Chain functions to ensure alignment on the
required risk, compliance and traceability processes as main client of the role
* Collaborate with Quality, Regulatory, IT, Legal, Commercial, Clinical
Supply Chain and Logistics teams to align initiatives with business goals.
* Manage relationships with solution providers, technology vendors, and thirdparty logistics partners.
Team Leadership & Development
* Directly manage and develop a global team, focusing on talent development
and program continuity.
* Provide leadership to cross-functional teams and foster a culture of
accountability, innovation, and continuous improvement.

SCOPE

This role is responsible for supporting the efficient movement of lifesaving therapies in
compliance with applicable regulations. Decisions made in this role are of critical
nature in mitigating risks for the business while ensuring
BioMarin's commercial products are delivered to patients in a compliant
and timely manner.
The candidate should demonstrate the following attributes:
* A firm commitment to BioMarin's cultural beliefs and values
* Consistent track record of exceeding objectives within area of influence
* Ability to achieve results through others without direct reporting lines
* Strong problem-solving skills with a global focus both internally and externally
* Possess a high level of accountability and demonstrate an ability to be a
change agent in a highly regulated industry
* Flexibility and ability to deal with changing priorities without losing sight of the
overall business
* Strong interpersonal, communication and influencing skills working with all
levels and within an environment of constant change
* Proactive and energetic outlook with an unwillingness to accept the status quo
* Interaction and collaboration with team members, peers and senior
management
* Ability to work independently with strong time management skills

EDUCATION
* Bachelor's or Master's degree in Engineering, Supply Chain, Life Sciences, or
related field.
* Minimum 10-12 years of experience in pharmaceutical supply chain, with
significant expertise in risk, security, traceability, cold chain and GDP
compliance.
* Proven leadership experience in a global, matrixed organization.
* Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.).
* Excellent communication, stakeholder management, and problem-solving
skills.

Preferred Qualifications:
* Experience with biologics, vaccines, or advanced therapies.
* Familiarity with digital monitoring systems and data analytics in cold chain.
* Lean Six Sigma or similar process improvement certification.

EXPERIENCE
* Bachelor's degree in related curriculum with a minimum of 10-12 years of
experience in Cold Chain, Traceability and Risk Management
* Previous experience leading a global team
* Thorough understanding of technology tools, cold chain related systems and
ERP systems, with a proven record of implementing scalable compliance
solutions (systems, procedures, and processes).
* Strong analytical and organizational skills with the ability
to anticipate problems and take proactive actions to make the company's
Trade Compliance stronger and more efficient.
* Proven ability to lead change initiatives and drive improvements within and
across functions which enable compliance and mitigate risk
* Ability to effectively work autonomously and independently

WORK ENVIRONMENT / PHYSICAL DEMANDS
The work environment characteristics described here are representative of those an
employee encounters while performing the essential functions of this
job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
The employee may frequently be required to sit and talk or hear. The employee is
occasionally required to stand; walk; use hands and fingers, handle, or feel; reach
with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or
smell. The employee must occasionally lift and/or move up to 25 pounds. Specific
vision abilities by this job include close vision, depth perception and ability to adjust
focus.
Approximately 15% travel

EQUIPMENT
Standard office desk equipment

CONTACTS
Commercial, Site Operations, Clinical Supply Chain Operations, Worldwide Research
& Development Scientists, Contract Manufacturing, Quality Assurance, Finance
External partners including 3PL providers, transport carriers.

SUPERVISOR RESPONSIBILITY
There will be personnel supervisor responsibility associated with this role.

CAREER DEVELOPMENT
Refer to Responsibilities section

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.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.