Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead compliance initiatives in pharmacovigilance and ensure regulatory standards are met.
- Company: Join BioMarin, a pioneering biotech firm transforming genetic discoveries into life-changing medicines.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and contribute to groundbreaking therapies.
- Qualifications: 10+ years in healthcare compliance with strong leadership and communication skills.
- Other info: Dynamic team environment with a focus on innovation and collaboration.
The predicted salary is between 72000 - 108000 ÂŁ per year.
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.
The GVP Compliance Lead 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
- Championing 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
EXPERIENCE AND QUALIFICATIONS
Required Skills
- 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)
EDUCATION
Bachelor’s Degree within a life science focus area, master’s degree is a plus
SUPERVISOR RESPONSIBILITY
(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.
ONSITE, REMOTE, OR FLEXIBLE
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 REQUIRED
May travel up to 10-20% of the time.
Director, GVP Compliance in London employer: BIOMARIN
Contact Detail:
BIOMARIN Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, GVP Compliance in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching BioMarin and its mission. Understand their approach to compliance and pharmacovigilance. We want you to show that you’re not just another candidate, but someone who genuinely cares about their work and can contribute to their goals.
✨Tip Number 3
Practice your pitch! You need to be able to clearly articulate your experience and how it aligns with the GVP Compliance Lead role. We suggest rehearsing with a friend or in front of a mirror to boost your confidence before the big day.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in showing your enthusiasm for the position. We believe that this small gesture can set you apart from other candidates and keep you fresh in their minds.
We think you need these skills to ace Director, GVP Compliance in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in Pharmacovigilance and compliance. We want to see how your skills align with our mission at BioMarin, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills: As a GVP Compliance Lead, you’ll be managing a team and collaborating with various stakeholders. Use your application to demonstrate your leadership experience and how you've successfully driven compliance projects in the past. We love seeing examples of strategic thinking and effective communication!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure your key points stand out. This will help us quickly understand your qualifications and fit for the role.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at BIOMARIN
✨Know Your GVP Inside Out
Make sure you brush up on Good Pharmacovigilance Practices and global regulations. Be ready to discuss how your experience aligns with these standards, as this role is all about compliance and quality assurance.
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've successfully led teams, managed audits, or navigated regulatory inspections in the past. Highlight your strategic thinking and decision-making skills.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating your thoughts clearly, especially when discussing complex compliance issues. Be prepared to present your ideas to senior leadership, showcasing your ability to convey important information succinctly.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think of situations where you've identified compliance risks or implemented quality improvements. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
