Director, GVP Compliance

OverviewBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, BioMarin has applied its scientific expertise to create transformative medicines for genetic conditions, using multiple treatment modalities. BioMarin develops medicines for patients with significant unmet medical need using genetics and molecular biology, and fosters an environment for bold, innovative science.About Technical OperationsBioMarin’s Technical Operations group creates drugs for clinical trials and scales production for the commercial market. Engineers, technicians, scientists and support staff build and maintain manufacturing processes, provide quality assurance and quality control to meet regulatory standards, procure goods and services to support manufacturing, and coordinate the movement of drugs to patients worldwide.TITLE GVP Compliance LeadSummaryBioMarin is a world leader delivering therapeutics for serious, life-threatening rare genetic diseases. We are seeking an individual with experience in Pharmacovigilance (PV) within Quality and Compliance. This role joins the Global Quality organization and reports to the Head of R&D Compliance. The GVP Compliance Lead advises internal and external stakeholders on Good Pharmacovigilance Practices (GVP) and leads a team that assesses compliance with global regulations, corporate policies, and standard operating procedures. The role partners with the GCP and GLP Compliance leads to oversee and execute the BioMarin R&D Audit Program, supports GVP regulatory inspections, and collaborates with stakeholders to resolve regulatory compliance risks and issues.BioMarin emphasizes initiative, clear communication, collaboration, strategic thinking and sound decision making. Candidates should adhere to established processes and policies, demonstrate professionalism and integrity, and ensure patient safety through regulatory compliance, risk management, pharmacovigilance, and continuous improvement.ResponsibilitiesChampion the implementation of Global Quality vision, policies, processes, and decisionsCollaborate with stakeholders to identify, communicate, and mitigate compliance risksEnhance 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 changesDevelop and enhance GVP Compliance processes and best practicesLead the execution of the GVP Compliance Global Audit ProgramAct as a GVP compliance core team member on regulatory inspection teams and support mock readinessProvide insights to optimize the GVP Compliance Audit ProgramContribute to Pharmacovigilance System Master File (PSMF) updatesCore member and contributor to REMS compliance programBuild a high-functioning team to ensure GVP compliance and foster teamworkMentor and develop staff to reach their potentialConduct management activities, including staffing, budget monitoring, and strategic planningManage recruiting, hiring, and evaluations with HR and Global Quality leadershipExperienceRequired Skills:10+ years in a regulated healthcare industry with a role in quality and complianceWorking knowledge of FDA, EMA, global PV Regulations, GVP, ICH and GCPExperience in Pharmacovigilance within Quality and ComplianceExperience executing or managing Health Authority InspectionsExperience executing or managing R&D Audits and GVP Audit ProgramExperience identifying strategies for a GVP audit program with internal auditors and external consultantsExperience navigating a quality management systemCore leadership competencies in strategic thinking, agility, prioritization, communication and decision makingExperience managing staff and leading teamsStrong verbal, written and oral communication; able to present to Senior LeadershipAbility to work independently and adapt to changing prioritiesStrong computer skills including MS Office and Quality Management SystemsDesired Skills:Experience with Business Development partnerships, mergers and/or acquisitionsExposure to pharmaceutical drug development or post-marketing surveillanceAwareness of core PV responsibilities (risk management, risk minimization, signal management, case processing)Compliance oversight of REMS ProgramsEducationBachelor’s Degree in a life science focus; master’s degree is a plusEquipmentQuality Management System (eQMS)ContactsHead of R&D Quality; GCP Compliance Lead; GLP Compliance Lead; Head of Global PV Operations; Regulatory Affairs; Commercial OperationsSupervisor ResponsibilityDirect reports:Associate Director, GVP ComplianceSenior Manager, GVP ComplianceManager, GxP ComplianceShift DetailsShift is 8 hours per day. For EU employees, shifts include at least two days per week with overlap with US hours.Onsite, Remote, or FlexibleThis role can be remote, covering EU and US time zones. No strict onsite requirement, but staff near the BioMarin SRC and Novato offices may be onsite per hybrid role requirements.Travel RequiredMay travel up to 10-20% of the timeWe are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other protected characteristic.Note: This description is not all-inclusive and may include other duties as assigned. Equal Opportunity Employer/Veterans/Disabled. Salary range: $176,000 to $242,000. Benefits include medical, dental, vision, and life insurance. This position may be eligible for discretionary bonuses and other compensation and benefits per policy. For benefits information, visit: https://careers.biomarin.com/benefits. #J-18808-Ljbffr