Associate Director, GVP Compliance

biomarin; Cork; On-site; EUR 120,000 - 150,000; Full time

Job summary

BioMarin seeks an Associate Director, GVP Compliance to lead pharmacovigilance governance within Global Quality. The role advises on GVP matters, audits, inspections, and risk-based compliance across global regs, corporate policies, and SOPs.

You will mentor junior staff, drive continuous improvement, and partner with Regulatory Affairs, PV Operations, and Commercial teams to ensure patient safety and regulatory readiness in a hybrid Cork, Ireland-based environment.

Qualifications

• 8+ years in regulated healthcare QA/compliance
• PV regulations knowledge (FDA/EMA/global)
• Experience in PV within Quality & Compliance
• Experience with Health Authority Inspections
• Experience with PV audits and GVP program
• Knowledge of quality management systems
• Strong communication and leadership skills

Responsibilities

• Lead GVP compliance programs and audits
• Advise on regulatory inspections and risk management
• Drive continuous improvement in PV governance
• Mentor staff and collaborate with PV operations, QA, and Regulatory
• Stay updated on global PV regulations and industry standards

Skills

Quality & Compliance

PV regulations

GVP Audits

GVP Strategy

QMS

Strategic thinking

Communication

Independent work

MS Office & QMS tools

Education

Bachelor’s in life sciences

Master’s degree (nice to have)

Tools

MS Office

Job description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia, PKU, CLN2, a form of Batten disease, and various forms of MPS offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, extending our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our drugs to patients.

Associate Director, GVP Compliance

Shanbally, Ringaskiddy, Cork • Hybrid role (2 days per week onsite)

SUMMARY

BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑threatening rare genetic diseases. We are looking for an individual with experience working in Pharmacovigilance (PV) within Quality and Compliance. This important role will join our Global Quality organization and report to the GVP Compliance Lead.

This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters, assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. It performs GVP audits, supports the readiness and execution of GVP regulatory inspections, and works with stakeholders to resolve regulatory compliance risks and related issues.

We value initiative, clear communication, effective collaboration, strategic thinking, and strong decision‑making. Candidates must adhere to established processes and policies, demonstrate professionalism and integrity, and ensure patient safety 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
• Contribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Contribute to building a team that ensures GVP compliance and fosters 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 capacity in 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 identifying optimal strategy for executing a GVP audit program 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 (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

CONTACTS

• Head of R&D Quality
• GCP Compliance Team
• GLP Compliance Team
• Head of Global PV Operations
• Regulatory Affairs
• Commercial Operations

SHIFT DETAILS

Shift will be 8 hours per day. If EU employee identified, shifts include at least 2 days per week with required partial overlap with the US EST and PST hours of operation.

ONSITE, REMOTE, OR FLEXIBLE

This role has the flexibility to be a remote position, covering both EU and US time zones. There is no requirement to be strictly onsite, however, staff local to the SRC, Shanbally, Dublin, London, and Novato offices will be expected to be onsite following the hybrid role requirements.

TRAVEL REQUIRED

May travel up to 25% of the time.

Equal Opportunity Employer

We are an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

NOTE

This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assigned.