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Director, GVP Compliance

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BioMarin Pharmaceutical

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Location:
United Kingdom , London

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

BioMarin is looking for a GVP Compliance Lead to advise internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and lead a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The role partners with the GCP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program and is a key point of contact supporting the planning and execution of GVP regulatory inspections.

Job Responsibility:

  • 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

Requirements:

  • 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
  • Bachelor’s Degree within a life science focus area

Nice to have:

  • 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)
  • master’s degree is a plus

Additional Information:

Job Posted:
January 09, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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