BioMarin Pharmaceutical Inc. · 4 days ago
Director, GVP Compliance
United States
Full-time
Remote
Director/Executive
$176K/yr - $242K/yr
10+ years expBioMarin Pharmaceutical Inc. is a global biotechnology company focused on developing transformative medicines for genetic diseases. They are seeking a GVP Compliance Lead to advise on Good Pharmacovigilance Practices and lead a team to ensure compliance with global regulations and corporate policies.
BiotechnologyDeveloper PlatformPharmaceutical
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
Qualification
Required
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, master's degree is a plus
Preferred
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)
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
BioMarin Pharmaceutical Inc.
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery.
1001-5000 employees
H1B Sponsorship
BioMarin Pharmaceutical Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (23)
2023 (24)
2022 (26)
2021 (24)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$585.8M2020-05-11Post Ipo Debt· $585.8M
1999-07-26IPO
Leadership Team
Brian Mueller
Chief Financial Officer
Arpit Davé
Executive Vice President, Chief Digital and Information Officer
Recent News
2026-01-13
Morningstar.com
2026-01-09
Company data provided by crunchbase