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 peoples 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 a number of forms of MPS offer new possibilities for patients and families who previously had few, if any, available options. With the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding 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 OperationsBioMarin’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 ComplianceDublinHybrid role: 2 days per week onsiteClosing date: 24 June 2026SummaryBioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. The Associate Director of Global Value-based Performance (GVP) Compliance will support the Global Quality organization and reports to the GVP Compliance Lead. This role advises internal and external stakeholders on Good Pharmacovigilance Practices (GVP) matters and assesses compliance with global regulations, corporate policies, and SOPs. The incumbent will perform GVP audits, support readiness and execution of GVP regulatory inspections, and collaborate with stakeholders to resolve regulatory compliance risks and related issues. BioMarin is a high-performing, team-based organization. The candidate must demonstrate initiative, clear communication, effective collaboration, strategic thinking and strong decision-making skills. 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.ResponsibilitiesAdvancing the execution of the Global Quality vision, policies, processes, and decisionsCollaborate with stakeholders to identify, communicate, and mitigate compliance risksContinually enhance partnerships with key stakeholders and leaders across the businessSupport and drive the implementation of quality and compliance projects and objectivesStay updated on regulations and recommend proactive compliance changes when necessaryExecute against GVP Compliance processes and best practicesPerform GVP audits and contribute to the effective implementation of the Global GVP Audit ProgramAct as a GVP compliance core team member on regulatory inspection teams and support mock readiness activitiesProvide insights to continually optimize the GVP Compliance Audit ProgramContribute to Pharmacovigilance System Master File (PSMF) updatesContribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance programContribute to building a team that ensures GVP compliance and fosters a culture of teamwork and mutual respectMentor and support the development of junior staff to achieve their full potentialExperienceRequired Skills8+ years of experience working within a regulated healthcare industry including a role in capacity of quality and complianceWorking knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulationsExperience working in Pharmacovigilance within Quality and ComplianceExperience executing or managing Health Authority InspectionsExperience executing or managing R&D Audits and GVP Audit ProgramExperience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultantsExperience navigating and understanding a quality management systemCore competencies in strategic thinking, agility, prioritization, communication and decision makingStrong verbal, written and oral communication skills; able to present to Senior LeadershipAble to work independently and be flexible to rapidly changing prioritiesStrong computer skills including working within the MS Suite of tools, and interfacing with Quality Management SystemsDesired SkillsExperience with Business Development partnerships, mergers and or acquisitionsExposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicinesAwareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processingCompliance oversight of REMS Program(s)EducationBachelor’s Degree within a life science focus area, master’s degree is a plusContactsHead of R&D QualityGCP Compliance TeamGLP Compliance TeamHead of Global PV OperationsRegulatory AffairsCommercial OperationsSupervisor ResponsibilityNoneShift DetailsShift 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 FlexibleThis 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 RequiredMay travel up to 25%+ of the timeEqual Opportunity Employer StatementWe 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.
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