Description

Who We Are

It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.

Title: Associate Director, Audits - Good Pharmacovigilance Practices (GVP) / Drug Safety

Location: Remote

Travel: Up to 40% domestic and international 

Role Overview

We are seeking a highly experienced Associate Director, Audits for Good Pharmacovigilance Practices (GVP) and Drug Safety to lead third-party and internal audits, ensuring compliance with global pharmacovigilance standards.

Key Responsibilities

• Lead internal and external risk-based audits
• Drive risk-based audit schedule
• Conduct pre-audit meetings with internal stakeholders
• Define the audit agenda, identifying and focusing on high-risk areas
• Execute audits and manage associated administrative tasks
• Prepare and distribute audit reports, ensuring timely communication with auditees and stakeholders
• Assist in identifying compliance gaps and coordinate CAPA remediation efforts
• Serve as a subject matter expert for GVP audits, providing researched, fact-supported information on complex issues
• Collaborate with cross-functional partners to build relationships and identify audit needs
• Maintain performance metrics in alignment with departmental KPIs
• Maintain current expertise in the field
• Other duties as assigned

 

Requirements

• Bachelor's Degree in life sciences; Advanced Degree (Masters) in a scientific discipline preferred
• 10+ years of experience within the regulated healthcare industry, with extensive knowledge of global GVP regulations
• Auditor certification preferred, e.g., ASQ
• Working knowledge of FDA Drug Safety Regulations and EMA GVP, with an understanding of their practical application
• Strong verbal, written, and oral communication skills; able to present audit and compliance information to senior management
• Ability to work independently and adjust to changing priorities
• Proficient in computer skills, including word processing, spreadsheets, and presentations

Work Environment

This position will be based remotely. Travel to San Rafael, California (Headquarters) is expected annually, at minimum, to engage in meetings with Team Members, Senior Leadership and Stakeholders as necessary

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.