Director, GVP Compliance

BioMarin Pharmaceutical Inc.; San Rafael (CA); Hybrid; USD 176,000 - 242,000; Full time

Benefits offered by this job

Company-sponsored medical, dental, vision, and life insurance

Discretionary annual bonus

Discretionary stock-based incentives

Job summary

A biotechnology company is seeking a GVP Compliance Lead in San Rafael, CA. This role involves overseeing compliance with Good Pharmacovigilance Practices and leading audit programs. The ideal candidate should possess over 10 years of experience in quality and compliance within a healthcare setting and show strong leadership abilities. This position allows flexible remote work and requires some travel. The salary range is $176,000 to $242,000 alongside benefits and potential bonuses.

Qualifications

• 10+ years of experience in a regulated healthcare industry.
• Working knowledge of global PV regulations.
• Experience managing Health Authority Inspections.
• Experience executing R&D Audits and GVP Audit Programs.
• Strong verbal, written, and oral communication skills.

Responsibilities

• Champion the implementation of Global Quality vision.
• Collaborate with stakeholders to mitigate compliance risks.
• Lead GVP Compliance Global Audit Program.
• Contribute to Pharmacovigilance System Master File updates.
• Mentor and develop staff to achieve their full potential.

Skills

Regulatory knowledge

Quality and compliance expertise

Leadership

Communication skills

Flexibility

Education

Bachelor’s Degree in life science

Master’s Degree

Tools

Quality Management System (eQMS)

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: https://careers.biomarin.com/benefits.