Associate Director, GVP Compliance
BioMarin Pharmaceutical Inc.
August 31, 2026
Remote friendly (United States)
United States
$153,600 - $211,200 USD yearly
Operations
Summary
- Pharmacovigilance (PV) role within Quality and Compliance, reporting into the GVP Compliance Lead.
Responsibilities
- Advancing the execution of the Global Quality vision, policies, processes, and decisions.
- Collaborating with stakeholders to identify, communicate, and mitigate compliance risks.
- Supporting and driving implementation of quality and compliance projects and objectives.
- Staying updated on regulations and recommending proactive compliance changes.
- Executing GVP compliance processes and best practices.
- Performing GVP audits and contributing to the Global GVP Audit Program.
- Serving as a core team member on regulatory inspection teams and supporting mock readiness activities.
- Providing insights to optimize the GVP Compliance Audit Program.
- Contributing to Pharmacovigilance System Master File (PSMF) updates.
- Contributing to the Risk Evaluation and Mitigation Strategies (REMS) compliance program.
- Building a GVP-compliance team culture and mentoring/developing junior staff.
Required Skills / Qualifications
- 8+ years in a regulated healthcare industry in a quality and compliance capacity.
- Working knowledge of FDA/EMA/global PV regulations; application of GVP, ICH, and GCP.
- PV experience within Quality and Compliance.
- Experience executing/managing Health Authority Inspections.
- Experience executing/managing R&D Audits and GVP Audit Program.
- Experience creating strategy for GVP audits with internal auditors and external consultants.
- Experience with quality management systems.
- Strategic thinking, agility, prioritization, communication, and decision making.
- Strong verbal/written communication; able to present to senior leadership.
- Ability to work independently and adapt to changing priorities.
- Strong computer skills (MS Suite) and interfacing with Quality Management Systems.
Desired Skills
- Business development partnerships, mergers, and/or acquisitions.
- Exposure to drug development phases or post-marketing surveillance.
- Understanding PV responsibilities (risk management/minimization, signal management, case processing).
- Compliance oversight of REMS program(s).
Education
- Bachelor’s degree in a life science focus area; master’s degree preferred.
Travel
- May travel up to 25%+.
- Pharmacovigilance (PV) role within Quality and Compliance, reporting into the GVP Compliance Lead.
Responsibilities
- Advancing the execution of the Global Quality vision, policies, processes, and decisions.
- Collaborating with stakeholders to identify, communicate, and mitigate compliance risks.
- Supporting and driving implementation of quality and compliance projects and objectives.
- Staying updated on regulations and recommending proactive compliance changes.
- Executing GVP compliance processes and best practices.
- Performing GVP audits and contributing to the Global GVP Audit Program.
- Serving as a core team member on regulatory inspection teams and supporting mock readiness activities.
- Providing insights to optimize the GVP Compliance Audit Program.
- Contributing to Pharmacovigilance System Master File (PSMF) updates.
- Contributing to the Risk Evaluation and Mitigation Strategies (REMS) compliance program.
- Building a GVP-compliance team culture and mentoring/developing junior staff.
Required Skills / Qualifications
- 8+ years in a regulated healthcare industry in a quality and compliance capacity.
- Working knowledge of FDA/EMA/global PV regulations; application of GVP, ICH, and GCP.
- PV experience within Quality and Compliance.
- Experience executing/managing Health Authority Inspections.
- Experience executing/managing R&D Audits and GVP Audit Program.
- Experience creating strategy for GVP audits with internal auditors and external consultants.
- Experience with quality management systems.
- Strategic thinking, agility, prioritization, communication, and decision making.
- Strong verbal/written communication; able to present to senior leadership.
- Ability to work independently and adapt to changing priorities.
- Strong computer skills (MS Suite) and interfacing with Quality Management Systems.
Desired Skills
- Business development partnerships, mergers, and/or acquisitions.
- Exposure to drug development phases or post-marketing surveillance.
- Understanding PV responsibilities (risk management/minimization, signal management, case processing).
- Compliance oversight of REMS program(s).
Education
- Bachelor’s degree in a life science focus area; master’s degree preferred.
Travel
- May travel up to 25%+.