Associate Director, GVP Compliance

Company Overview

BioMarin is a pioneering biotechnology company specializing in rare genetic diseases. Since 1997, BioMarin has developed treatments that significantly improve lives for patients facing conditions such as achondroplasia, PKU, Batten disease, and various forms of mucopolysaccharidosis. Recently, their portfolio expanded through acquisition to include therapies for Fabry and Pompe diseases, broadening their reach to more patients worldwide. The company values scientific excellence, patient-centered innovation, and high-quality manufacturing capabilities.

About Technical Operations

The Technical Operations team at BioMarin is responsible for producing drugs for clinical trials and commercial distribution. This includes maintaining innovative manufacturing processes, ensuring regulatory compliance through quality assurance/control, procuring necessary resources, and managing the global supply chain to deliver medicines to patients.

Role Summary

The Associate Director of Good Pharmacovigilance Practice (GVP) Compliance will join BioMarin's Global Quality department in Dublin, working in a hybrid capacity. This role reports to the GVP Compliance Lead and serves as a key advisor on GVP regulatory adherence, corporate policies, and standard operating procedures. Responsibilities include conducting GVP audits, supporting regulatory inspections and readiness, and collaborating with stakeholders to manage compliance risk.

Key Responsibilities

• Drive the implementation of global quality initiatives, policies, and processes aligned with GVP compliance.
• Partner with internal and external stakeholders to identify and mitigate compliance risks.
• Enhance collaboration across the organization and maintain strong working relationships with leadership teams.
• Lead quality and compliance projects, ensuring objectives are met efficiently.
• Monitor regulatory developments and proactively recommend compliance adaptations.
• Execute GVP Compliance procedures and promote continuous improvement in audit programs.
• Conduct GVP audits and contribute to the Global GVP Audit Program’s effectiveness.
• Participate in regulatory inspection teams and support mock inspections to ensure readiness.
• Provide insights to optimize the GVP Compliance Audit Program continually.
• Assist with updates to the Pharmacovigilance System Master File (PSMF).
• Contribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance initiatives.
• Support the development of a cohesive team culture emphasizing compliance and mutual respect.
• Mentor junior colleagues to foster professional growth and capability development.

Qualifications and Experience

• At least 8 years’ experience within a regulated healthcare environment, focused on quality and compliance.
• Comprehensive understanding of FDA, EMA, and global pharmacovigilance regulations and practices including GVP, ICH, and GCP requirements.
• Hands-on experience in pharmacovigilance quality and compliance functions.
• Proven ability to lead or manage health authority inspections and R&D audits, including execution of GVP audit programs.
• Skilled in designing and implementing GVP audit strategies involving internal auditors and external consultants.
• Familiarity with quality management systems and regulatory compliance frameworks.
• Strong strategic thinking, adaptability, prioritization, communication, and decision-making abilities.
• Excellent verbal and written communication skills with the ability to present to senior leadership.
• Self-motivated and able to manage shifting priorities independently.
• Proficient with MS Office tools and Quality Management System software.

Preferred Skills

• Experience with business development, partnerships, mergers, or acquisitions.
• Knowledge of pharmaceutical drug development phases and post-marketing surveillance.
• Understanding of pharmacovigilance core functions such as risk management, signal detection, and case processing.
• Experience with compliance oversight of REMS programs.

Education

Bachelor’s degree in a life sciences discipline is required; a master’s degree is advantageous.

Additional Information

• Work schedule: 8 hours a day with at least two days per week overlap with US EST and PST hours for EU employees.
• This role offers flexibility with a hybrid work model: two days onsite per week in Dublin and remote coverage across EU and US time zones.
• Travel up to 25% or more may be required.
• There are no direct supervisory responsibilities.
• BioMarin is committed to equal employment opportunity without discrimination.
• This job description outlines general duties and is not exhaustive; other responsibilities may be assigned.