Senior Manager, QA Systems and Compliance

Responsibilities

• Act as Business Process Owner for assigned Quality Systems, providing strategic direction and oversight.
• Assess GMP and regulatory compliance risks and develop effective mitigation strategies.
• Support site audit and inspection activities, including preparation, participation, and follow-up.
• Oversee the Site Quality Management Review process to evaluate quality performance.
• Collaborate with cross-functional leadership to design and implement system improvements.
• Analyze system performance using metrics and KPIs to drive data-based decision making.
• Lead, coach, and mentor a team of Quality Specialists, associates, and contingent workers.
• Manage talent acquisition, performance management, and resource planning for the team.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Process Engineering, or a related discipline.
• 15–20+ years of experience within GMP-regulated pharmaceutical or biotechnology environments.
• 3–5 years of experience in leadership roles with proven people management skills.
• Significant hands-on experience supporting regulatory inspections.
• Strong knowledge of EU GDP Guidelines and regional regulatory requirements.
• Proven ability to lead change initiatives and drive continuous improvement.
• Excellent stakeholder engagement and communication skills.

About the Company

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. We are dedicated to delivering innovative treatments to patients and families around the world through scientific expertise and world-class manufacturing capabilities.