Site Risk Management Lead

Description

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.

Site Risk Management Lead

Hybrid (3 days onsite p/w)

Shanbally, Ringaskiddy, Cork

Closing Date: 10th July 2026

Role Purpose

The Site Risk Management Lead is responsible for establishing and leading the overall risk management framework across the Shanbally site. This role provides a holistic, cross-functional view of risks impacting operations, supply continuity, financial performance, compliance, reputational and site strategy.

The position enables informed, risk-based decision-making by identifying, assessing, and driving mitigation of key business risks. Functional leaders retain ownership of risks and mitigation actions within their areas; the Site Risk Management Lead provides the framework, governance, oversight, and challenge to ensure consistency, visibility, and effective risk reduction.

Key Responsibilities:

Development of Risk Management Framework

• Develop and implement a site-wide risk management framework
• Define and maintain a consistent risk classification across functions (operational, supply chain, financial, compliance, strategic, Infrastructure & Technology, People etc.)
• Establish and maintain a central site risk register

Risk Identification & Assessment

• Facilitate cross-functional risk identification workshops with functional leadership teams (e.g Manufacturing, Supply Chain, Engineering, Quality, and Finance) & Cross functional teams (e.g Flow Teams)
• Identify and maintain visibility of Top Site Risks (e.g. Top 5 per area / node)
• Implement a structured risk assessment methodology (impact, likelihood, detectability etc.)

Risk Mitigation & Ownership

• Partner with functional leaders to define risk mitigation strategies
• Ensure clear ownership and accountability for all identified risks
• Track and challenge progress of mitigation plans to ensure timely execution

Risk Governance & Reporting

• Establish and lead a Site Risk Review Board leveraging existing governance forums where possible
• Support regular (monthly/quarterly) risk review cycles with functional leadership teams
• Provide clear, data-driven risk reporting and insights to support decision-making

Cross-Functional Integration

• Embed risk management into key business processes, including:
  • Investment decisions
  • Operational strategy
  • Supply strategy (via S&OP & Site Business Planning processes)
  • Business Continuity planning
• Collaborate with Quality to ensure alignment with GMP risk management without duplication
• Provide independent support for scenario planning using risk-benefit analysis tools to improve decision-making effectiveness (e.g. Monte Carlo simulation)

Continuous Improvement

• Drive a risk-aware culture across the site
• Simplify and standardize risk tools and processes for practical use
• Leverage data and trends to proactively identify emerging risks

Key Interfaces

• Site Leadership Team
• Flow Teams
• Manufacturing & Operations
• Supply Chain & Planning
• Engineering & Maintenance
• Project Management Office (PMO)
• Finance
• Quality Assurance
• Business Continuity Planning

Qualifications & Experience

Required:

• Bachelor’s degree in Engineering, Science, Business, or related field
• Significant experience in a pharmaceutical or regulated manufacturing environment
• Strong understanding of manufacturing operations and supply chain dynamics
• Proven experience in risk management, operations, or strategic roles

Preferred:

• Experience in Enterprise Risk Management (ERM) frameworks
• Knowledge of business continuity planning
• Familiarity with GMP environments and regulatory expectations
• Experience with data analysis and risk quantification methods

Skills & Competencies

• Strong cross-functional leadership and influencing skills
• Ability to translate complex risks into clear business impacts
• Excellent facilitation and stakeholder engagement capabilities
• Strategic thinking with strong operational awareness
• Data-driven mindset with ability to prioritize effectively

Key Success Measures

• Clear visibility and management of Top Site Risks
• Effective risk mitigation execution across functions
• Integration of risk insights into business decision-making
• Increased awareness of risk & use of risk management tools across all tiers on site

Additional Notes

• This role operates independently of the Quality function and focuses on enterprise-level business risks
• Close collaboration with Quality is required to ensure alignment with regulatory risk management expectations
• The role is expected to challenge the site constructively and drive proactive, not reactive, risk management

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.