Associate Director, GVP Compliance

BioMarin Pharmaceutical Inc.

BioMarin seeks an Associate Director, GVP Compliance to support pharmacovigilance within Quality. Role involves compliance oversight, audits, and regulatory inspections in remote capacity.

Posted 6/5/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Advancing the execution of the 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 across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Execute against GVP Compliance processes and best practices
Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates
Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect
Mentor and support the development of junior staff to achieve their full potential

Requirements

What you’ll need

8+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core competencies in strategic thinking, agility, prioritization, communication and decision making
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.
Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems.

Benefits

Comp & perks

Equal Opportunity Employer/Veterans/Disabled

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Good Pharmacovigilance Practices (GVP)Pharmacovigilance (PV)Health Authority InspectionsR&D AuditsGVP Audit ProgramQuality Management SystemRegulatory ComplianceRisk Evaluation and Mitigation Strategies (REMS)GVP Compliance processesGVP Compliance Audit Program

Soft Skills

strategic thinkingagilityprioritizationcommunicationdecision makingmentoringteamworkinterpersonal skillsleadershipcollaboration