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GCP Compliance Lead

BioMarin Pharmaceutical Inc.
United States, United Statesfull_timeVerifiedPosted 14 Apr 2026

About the role

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 BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Clinical Development within the space of Quality and Compliance.  This important role will be joining our Global Quality organization and reports into the Head of R&D Compliance. This role is responsible for establishing, maintaining, and continuously improving the organization’s Good Clinical Practice (GCP) compliance framework to ensure subject safety, data integrity, and enforcing ethical principles across the clinical lifecycle.  As an advisor, the GCP Compliance Lead supports the internal and external key stakeholders on Good Clinical Practices (GCP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GCP Compliance Lead partners with our GVP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program.  This individual is also a key point of contact supporting the planning and execution of GCP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues. BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess. Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure clinical trial subject safety and data integrity through a comprehensive strategy that integrates GCP regulatory compliance, risk-based oversight, issue management, and continuous improvement. RESPONSIBILITIES  
  • Championing the implementation of Global Quality vision, policies, processes, and decisions
  • Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
  • Continually enhance partnerships with key stakeholders and leaders as a trusted advisor across the business
  • Support and drive the implementation of quality and compliance projects and objectives
  • Stay updated on regulations and recommend proactive compliance changes when necessary
  • Develop and enhance GCP Compliance processes and best practices
  • Maintain BioMarin processes to ensure evaluation & escalation of serious non-compliance
  • Lead the execution of the GCP Compliance Global Audit Program
  • Act as a GCP compliance core team member on regulatory inspection teams and support mock readiness activities
  • Provide insights to continually optimize the GCP Compliance Audit Program
  • Create a high-functioning team to ensure GCP compliance and foster a culture of teamwork and mutual respect
  • Mentor and develop staff to achieve their full potential
  • Conduct management activities, including staffing, budget monitoring, and strategic planning
  • Manage recruiting, hiring, and evaluations with HR and Global Quality leadership
 EXPERIENCE Required

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Company

BioMarin Pharmaceutical Inc.

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