Associate Director, GVP Compliance

About the Role

BioMarin is seeking an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance to join the Global Quality organization, reporting into the GVP Compliance Lead. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The individual will perform GVP audits and act as a key point of contact supporting the readiness and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues.

Responsibilities

• Advancing the execution of the 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
• Execute against GVP Compliance processes and best practices
• Perform GVP audits and contribute to the effective implementation of the Global GVP 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
• Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect
• Mentor and support the development of junior staff to achieve their full potential

Required Experience

• 8+ 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 competencies in strategic thinking, agility, prioritization, communication and decision making
• 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 Experience

• 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)

Qualifications

• Bachelor's Degree within a life science focus area

Travel

• May travel up to 25%+ of the time