Director, GVP Compliance

Biomarin; City of Westminster; Hybrid; GBP 80,000 - 110,000; Full time

Job summary

A leading biotechnology firm seeks an experienced GVP Compliance Lead in Westminster, UK. This role involves ensuring compliance with pharmacovigilance regulations and leading a team responsible for audits and regulatory inspections. Candidates must have over 10 years of experience in a regulated healthcare environment, familiarity with FDA and EMA standards, and strong leadership skills. The position offers flexibility for remote work while fostering a collaborative culture within the organization.

Qualifications

• 10+ years of experience in a regulated healthcare industry, especially in quality and compliance.
• Working knowledge of FDA and EMA regulations.
• Experience in managing GVP audits and regulatory inspections.

Responsibilities

• Champion the implementation of Global Quality vision and policies.
• Collaborate with stakeholders to identify compliance risks.
• Lead the execution of the GVP Compliance Global Audit Program.

Skills

Regulatory compliance

Quality management

Pharmacovigilance practices

Leadership

Communication skills

Education

Bachelor's Degree in Life Sciences

Master's Degree (preferred)

Tools

MS Office Suite

Quality Management Systems

Job description

BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑thriving rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance. This important role will be joining our Global Quality organization and reports into the Head of R&D Compliance. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GVP Compliance Lead partners with the GCP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program. This individual is also a key point of contact supporting the planning and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues. BioMarin is a global, high‑performing, team‑based organization, where colleagues are flexible, multi‑skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess. Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure patient safety in pharmaceutical practices through a comprehensive strategy that integrates regulatory compliance, risk management, pharmacovigilance, and continuous improvement.

Responsibilities

• Champion the implementation of 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.
• Develop and enhance GVP Compliance processes and best practices.
• Lead the execution of the GVP Compliance Global 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.
• Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program.
• Create a high‑functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect.
• Mentor and develop staff to achieve their full potential.
• Conduct management activities, including staffing, budget monitoring, and strategic planning.
• Manage recruiting, hiring and evaluations with HR and Global Quality leadership, Head of R&D Quality.
• Manage 3 direct reports: Associate Director, GVP Compliance; Senior Manager, GVP Compliance; Manager, GxP Compliance.

Shift Details

Shift will be 8 hours per day. If EU employee identified, shifts include at least 2 days per week with required partial overlap with the US EST and PST hours of operation.

Location / Remote Flexibility

This role has the flexibility to be a remote position, covering both EU and US time zones. There is no requirement to be strictly onsite, however staff local to the SRC and Novato offices will be expected to be onsite following the hybrid role requirements.

Travel Requirements

May travel up to 10‑20% of the time.

Qualifications

• 10+ 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 leadership competencies in strategic thinking, agility, prioritization, communication and decision making.
• Experience in managing staff and leading teams.
• Strong verbal, written and oral communication skills. Able to present to Senior Leadership.
• Able to work independently and be flexible to rapidly changing priorities.
• Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems.

Desired Skills

• Experience with Business Development partnerships, mergers and/or acquisitions.
• Exposure to working in any phase of pharmaceutical drug development or post‑marketing surveillance of medicines.
• Awareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing.
• Compliance oversight of REMS Program(s).
• Bachelor's Degree within a life science focus area, master's degree is a plus.

Equal Employment Opportunity

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.

Company Overview

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well‑understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options. BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.