Associate Director, GVP Compliance in London

Who

Are: Bio Marin 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.

Bio Marin’s therapies for conditions such as achondroplasia, PKU, CLN2, Batten disease, and various MPS, as well as Fabry and Pompe disease, offer new possibilities for patients and families who previously had few or no options.

Our success is rooted in a commitment to excellence, patient‑centric learning, scientific expertise, and world‑class manufacturing capabilities.

About Technical Operations

Bio Marin’s Technical Operations group creates our drugs for use in clinical trials and scales production for the commercial market.

Engineers, technicians, scientists, and support staff build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and quality control, and procure the goods and services required to support manufacturing and global distribution of our therapies.

Position: Associate Director, GVP Compliance

The role supports global quality, advising stakeholders on Good Pharmacovigilance Practices (GVP), assessing compliance with regulations and corporate policies, and leading GVP audits and inspection readiness.

Travel up to 25% of the time.

Flexibility to work remotely is available for EU and US time‑zones; onsite presence is required in the SRC, Shanbally, Dublin, London, and Novato offices per hybrid requirements.

Summary

As Associate Director, GVP Compliance you will advise internal and external stakeholders on GVP matters, assess compliance with global regulations, lead GVP audits, and support the readiness and execution of GVP regulatory inspections.

You will partner with stakeholders to resolve regulatory compliance risks, contribute to the Global GVP Audit Program, and ensure continuous improvement of pharmacovigilance practices.

Initiative, clear communication, strategic thinking, collaborative decision‑making, and integrity are essential.

Responsibilities

• Advance the execution of the Global Quality vision, policies, processes, and decisions.
• Collaborate with stakeholders to identify, communicate, and mitigate compliance risks.
• 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.
• Execute GVP compliance processes and best practices.
• Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program.
• Act as a 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.
• Contribute to the REMS compliance program.
• Build a team that ensures GVP compliance and fosters a culture of teamwork and mutual respect.
• Mentor and support the development of junior staff.
• Required Skills
• 8+ years in a regulated healthcare industry with a role in quality and compliance.
• Working knowledge of FDA, EMA, and global PV regulations, and application of GVP, ICH, and GCP.
• Experience in Pharmacovigilance (PV) within Quality and Compliance.
• Experience executing or managing Health Authority Inspections.
• Experience executing or managing R&D Audits and the GVP Audit Program.
• Experience developing optimal strategies for executing a GVP audit program 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; ability to present to senior leadership.
• Ability to work independently and adapt to rapidly changing priorities.
• Strong computer skills, including the Microsoft Office Suite and interfacing with Quality Management Systems.
• Desired Skills
• Experience with Business Development partnerships, mergers, and/or acquisitions.
• Exposure to any phase of pharmaceutical drug development or post‑marketing surveillance of medicines.
• Awareness and understanding of core PV responsibilities such as risk management, risk minimization measures, signal management, and case processing.
• Compliance oversight of REMS Program(s).

Education

Bachelor’s Degree in a life‑science focus area; a master’s degree is a plus.

Note

This description is not intended to be all‑inclusive, or a limitation of the duties of the position.

It describes the general nature of the job and may include other duties as assigned.

EEO Statement

We are an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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