Director, GVP Compliance

Role Summary

Director, GVP Compliance leads the Global Pharmacovigilance (PV) quality and compliance program within BioMarin’s Global Quality organization. This role advises internal and external stakeholders on Good Pharmacovigilance Practices (GVP), oversees global regulatory compliance, and partners with GCP and GLP to ensure timely execution of the R&D Audit Program. It also supports planning and execution of GVP regulatory inspections and works with stakeholders to resolve regulatory compliance risks.

Responsibilities

• Champion 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

Qualifications

• Required: 10+ years of experience in a regulated healthcare industry including a role in quality and compliance
• Working knowledge of FDA, EMA, and global PV Regulations, and application of 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 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 adapt to rapidly changing priorities
• Strong computer skills including MS Office and interfacing with Quality Management Systems
• Preferred: Experience with Business Development partnerships, mergers and/or acquisitions
• Exposure to pharmaceutical drug development or post-marketing surveillance of medicines
• Understanding of core PV responsibilities (risk management, risk minimization, signal management, case processing)
• Compliance oversight of REMS Program(s)

Skills

• Leadership and people-management
• Strategic thinking and risk assessment
• Regulatory knowledge across PV/GVP, GCP, GLP
• Communication and stakeholder management
• Project management and process improvement
• Quality management systems and audit execution

Education

• Bachelor‚Äôs Degree within a life science focus area; master‚Äôs degree is a plus

Additional Requirements

• Travel: May travel up to 10‚Äì20% of the time
• Remote/onsite: Flexible to remote position covering EU and US time zones; some onsite expectation for staff near specified offices per hybrid role requirements
• Physical/working conditions: Not specified as essential to job duties