Senior Manager, GMP/GDP Audit and Post Market Compliance

Responsibilities

• Establish and maintain a risk-based GMP/GDP audit program aligned with the Global Quality Management System and regulatory requirements.
• Manage the Global Recall process, including executing annual mock recalls and generating protocols and reports.
• Act as the Business Process Owner for the Quality Review Board (QRB) to manage global quality and compliance escalation processes.
• Lead the digital transformation of audit and compliance programs by implementing automation, advanced analytics, and AI-enabled solutions.
• Monitor and triage emerging GMP/GDP regulations to ensure timely assessment and compliance across the organization.
• Manage third-party audit service providers, including budget tracking and contract management.
• Partner with cross-functional teams such as Manufacturing, Regulatory, and IT to embed compliance requirements across the program lifecycle.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline.
• 10+ years of experience in Quality Assurance, Regulatory, Manufacturing, or related roles within a highly regulated industry (biotech or pharma).
• In-depth knowledge of global quality and regulatory requirements, including GMP, GDP, ISO standards, and 21 CFRs.
• Proven experience in audit and compliance program management within complex, global supply chain networks.
• Demonstrated ability to use data, analytics, and digital tools to improve quality outcomes.
• Strong leadership skills with the ability to influence stakeholders in a matrixed, global environment.

Preferred Qualifications

• Advanced degree (MS, PhD, or MBA).
• Six Sigma or Lean certification.
• Experience with AI-enabled solutions and digital quality strategies.

About the Company

BioMarin is a leading rare disease biotechnology company focused on developing medicines that make a profound impact on people’s lives. Since 1997, BioMarin has delivered revolutionary treatments for genetically defined conditions, leveraging world-class manufacturing capabilities and scientific expertise to reach patients and families worldwide.