Director, GVP Compliance - Remote

Overview

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. We are looking for an individual with experience working in Pharmacovigilance within the space of Quality and Compliance to support our important mission.

In Short

• Champion implementation of Global Quality vision and policies.
• Collaborate with stakeholders to identify compliance risks.
• Enhance partnerships with key stakeholders.
• Drive quality and compliance projects.
• Stay updated on regulations and recommend compliance changes.
• Lead GVP Compliance Global Audit Program.
• Support regulatory inspection teams.
• Mentor and develop staff.
• Manage recruiting and evaluations.
• Conduct management activities including budget monitoring.

Requirements

• 10+ years in regulated healthcare industry.
• Knowledge of FDA, EMA, and global PV Regulations.
• Experience in Pharmacovigilance within Quality and Compliance.
• Experience managing Health Authority Inspections.
• Leadership competencies in strategic thinking and decision making.
• Strong communication skills.
• Ability to work independently.
• Strong computer skills including MS Suite.

Benefits

• Flexible remote position.
• Opportunity to work with a high-performing team.
• Engagement in meaningful science.
• Professional development opportunities.
• Competitive salary and benefits.