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Gvp compliance lead

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BioMarin Pharmaceutical

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Location:
United States

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

176000.00 - 242000.00 USD / Year
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Job Description:

BioMarin is 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.

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
What we offer:
  • company-sponsored medical, dental, vision, and life insurance plans
  • discretionary annual bonus
  • discretionary stock-based long-term incentives
  • paid time off

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
Remote work
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