Associate Director, GVP Compliance

biomarin; Dublin; On-site; EUR 150,000 - 190,000; Full time

Job summary

BioMarin is seeking an Associate Director, GVP Compliance in Dublin to lead pharmacovigilance quality and compliance activities within the Global Quality organization. The role advises on GVP matters and coordinates audits, inspections, and risk mitigation.

Hybrid role (2 days on-site) with international scope, travel up to 25%, and mentorship of junior staff. This role reports into the GVP Compliance Lead and supports readiness for regulatory inspections.

Qualifications

• 8+ years in a regulated healthcare industry with quality and compliance responsibilities.
• Experience in Pharmacovigilance within Quality/Compliance and with GVP.
• Experience leading Health Authority inspections and audits.

Responsibilities

• Advance Global Quality vision, policies, and processes.
• Collaborate with stakeholders to mitigate compliance risks.
• Mentor junior staff and support development.
• Lead GVP audits and contribute to the audit program.
• Support regulatory inspections and mock readiness activities.
• Maintain PSMF updates and REMS compliance support.

Skills

GVP regulations

PV audits

Regulatory inspections

Quality management

Stakeholder communication

MS Suite

Cross-functional

Education

Bachelor's degree in life sciences

Tools

Quality Management System

MS Office

Job description

Associate Director, GVP Compliance

Location: Dublin

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.

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

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 / 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/Veterans/Disabled

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.

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.