GVP Compliance Lead — Global Quality & Audits

BioMarin Pharmaceutical Inc.; Cork; Hybrid; 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

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.