Associate Director, GVP Compliance

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 120,000 - 170,000; Full time

Job summary

BioMarin Pharmaceutical Inc. invites an Associate Director, GVP Compliance to join our Global Quality team in a hybrid role based near Cork.

You will advise on GVP matters, assess regulatory compliance, and support inspections and risk mitigation while collaborating with internal and external stakeholders. The role requires strong PV expertise, audit experience, and the ability to lead complex programs with senior leadership.

Qualifications

• Working knowledge of FDA, EMA, and global PV regulations and application of GVP/ICH/GCP.
• PV experience within Quality and Compliance.
• Experience executing/leading Health Authority inspections.
• Experience with GVP audit programs and working with internal/external auditors.
• Understanding of quality management systems and regulatory risk.

Responsibilities

• Advance the execution of the Global Quality vision and policies.
• Collaborate with stakeholders to identify and mitigate compliance risks.
• Drive partnerships across the business to enhance compliance.
• Lead and support quality and compliance projects and objectives.
• Stay updated on regulations and recommend proactive changes.
• Execute GVP compliance processes and best practices.
• Perform GVP audits and support the Global GVP Audit Program.
• Support regulatory inspections and mock readiness activities.
• Contribute to PSMF updates and REMS compliance.

Skills

GVP Regulations

Pharmacovigilance

Regulatory inspections

GVP Audit Program

Quality Management System

Strategic thinking

Communication

Independent work

Education

Bachelor's degree in life sciences

Tools

MS Office

Quality Management Software

Job description

Associate Director, GVP Compliance

Location: 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. 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 optimizethe 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:

• 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

Contacts

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

Supervisor Responsibility

None

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.