About this opportunity
BioMarin Pharmaceutical Inc. lists this Director, GVP Compliance opportunity in san rafael, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Who We Are
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.
Job Title
GVP Compliance Lead
Summary
BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑threatening 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 role will join our Global Quality organization and report to the Head of R&D Compliance. The GVP Compliance Lead advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and leads a team that collectively assesses compliance with global regulations, 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, supports the planning and execution of GVP regulatory inspections, and works with stakeholders to resolve regulatory compliance risks and related issues.
Responsibilities
Champion the implementation of the Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continuously 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
Required Skills
10+ years of experience working within a regulated healthcare industry, including a role in 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 identifying optimal strategy for executing a GVP audit program 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 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 such as 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.
Equipment
Quality Management System (eQMS)
Contacts
Head of R&D Quality, GCP Compliance Lead, GLP Compliance Lead, Head of Global PV Operations, Regulatory Affairs, Commercial Operations
Supervisor Responsibilities
Associate Director, GVP Compliance
Senior Manager, GVP Compliance
Manager, GxP Compliance
Shift Details
Shift will be 8 hours per day. If the employee is based in the EU, the shift includes at least 2 days per week with required partial overlap with the US Eastern and Pacific Standard Time 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.
Equal Opportunity Employer
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.
Salary Range
Salary range for this position is: $176,000 to $242,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
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Worksite address
san rafael, CA, 94911, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.