Associate Director, GVP Compliance

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. 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

EXPERIENCE Required Skills: 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 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 i.e., 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 TRAVEL REQUIRED May travel up to 25%+ of the time

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The salary range for this position is: $153,600 to $211,200. 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 a 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.