GCP Compliance Lead

Working knowledge of FDA, EMA, PMDA and global PV Regulations, and application of Good Clinical Practices (GCP), ICH and GCP regulations

Experience working in Clinical Development within Quality and Compliance

Experience executing or managing Health Authority Inspections

Experience executing or managing R&D Audits and GCP Audit Program

Experience with identifying optimal strategy for executing a GCP audit program working with internal auditors and external consultants

Experience navigating and understanding a quality management system

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

Develop and enhance GCP Compliance processes and best practices

Maintain BioMarin processes to ensure evaluation & escalation of serious non-compliance