Associate Director, GVP Compliance

BioMarin Pharmaceutical Inc.

About The Position

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 important role will be joining our Global Quality organization and reports 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. This 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. BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess. Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure patient safety in pharmaceutical practices through a comprehensive strategy that integrates regulatory compliance, risk management, pharmacovigilance, and continuous improvement.

Requirements

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

Nice To Haves

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)

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