Associate Director, GVP Compliance

<p>Who We Are <br /><br />BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.<br /><br />Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, 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.<br /><br />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. <br /><br />About Technical Operations <br /><br />BioMarin’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 coordinating the worldwide movement of our drugs to patients. <br /><br /></p><div><b><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;"> </span></b></div><div align="center" style="text-align: center;"></div><div> </div><div style="text-align: center;"><strong><span style="font-family: Arial , sans-serif;">Associate Director, GVP Compliance</span></strong></div><div style="text-align: center;"><strong><span style="font-family: Arial , sans-serif;">Shanbally, Ringaskiddy, Cork</span></strong></div><div style="text-align: center;"><strong><span style="font-family: Arial , sans-serif;">Hybrid role (2 days per week onsite)</span></strong></div><div> </div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">SUMMARY</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-family: Arial , sans-serif;">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.<span>  </span>This important role will be joining our Global Quality organization and reports into the GVP Compliance Lead.</span></div><div> </div><div><span style="font-family: Arial , sans-serif;">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.<span>  </span></span></div><div> </div><div><span style="font-family: Arial , sans-serif;">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.</span></div><div> </div><div><span style="font-family: Arial , sans-serif;">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.</span></div><div><span style="font-size: 10.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">RESPONSIBILITIES</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><ul style="margin-top: 0.0px;"><li><span style="font-family: Arial , sans-serif;">Advancing the execution of the Global Quality vision, policies, processes, and decisions</span></li><li><span style="font-family: Arial , sans-serif;">Collaborate with stakeholders to identify, communicate, and mitigate compliance risks</span></li><li><span style="font-family: Arial , sans-serif;">Continually enhance partnerships with key stakeholders and leaders across the business</span></li><li><span style="font-family: Arial , sans-serif;">Support and drive the implementation of quality and compliance projects and objectives</span></li><li><span style="font-family: Arial , sans-serif;">Stay updated on regulations and recommend proactive compliance changes when necessary</span></li><li><span style="font-family: Arial , sans-serif;">Execute against GVP Compliance processes and best practices</span></li><li><span style="font-family: Arial , sans-serif;">Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program</span></li><li><span style="font-family: Arial , sans-serif;">Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities</span></li><li><span style="font-family: Arial , sans-serif;">Provide insights to continually optimize the GVP Compliance Audit Program</span></li><li><span style="font-family: Arial , sans-serif;">Contribute to Pharmacovigilance System Master File (PSMF) updates</span></li><li><span style="font-family: Arial , sans-serif;">Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program</span></li><li><span style="font-family: Arial , sans-serif;">Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect</span></li><li><span style="font-family: Arial , sans-serif;">Mentor and support the development of junior staff to achieve their full potential</span></li></ul><div><span style="font-family: Arial , sans-serif;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">EXPERIENCE</span></u></b></div><div><b><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;"> </span></b></div><div><b><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">Required Skills:</span></b></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><div><span style="font-family: Arial , sans-serif;">8+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance</span></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><ul style="margin-top: 0.0px;"><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations</span></li><li><span style="font-family: Arial , sans-serif;">Experience working in Pharmacovigilance (PV) within Quality and Compliance </span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Experience executing or managing Health Authority Inspections</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Experience executing or managing R&D Audits and GVP Audit Program</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Experience navigating and understanding a quality management system</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Core competencies in strategic thinking, agility, prioritization, communication and decision making</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Strong verbal, written and oral communication skills.  Able to present to Senior Leadership.</span></li><li><span style="font-family: Arial , sans-serif;">Able to work independently and be flexible to rapidly changing priorities</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems</span></li></ul><div><b><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></b></div><div><b><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">Desired Skills:</span></b></div><div style="margin-left: 18.0pt;"><span style="font-family: Arial , sans-serif;"> </span></div><ul style="margin-top: 0.0px;"><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Experience with Business Development partnerships, mergers and/or acquisitions</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Awareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing</span></li><li><span style="font-size: 11.0pt;font-family: Arial , sans-serif;">Compliance oversight of REMS Program(s)</span></li></ul><div><span style="font-size: 10.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">EDUCATION</span></u></b></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div><span style="font-family: Arial , sans-serif;">Bachelor’s Degree within a life science focus area, master’s degree is a plus</span></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">CONTACTS</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><div><span style="font-family: Arial , sans-serif;">Head of R&D Quality </span></div><div><span style="font-family: Arial , sans-serif;">GCP Compliance Team</span></div><div><span style="font-family: Arial , sans-serif;">GLP Compliance Team</span></div><div><span style="font-family: Arial , sans-serif;">Head of Global PV Operations</span></div><div><span style="font-family: Arial , sans-serif;">Regulatory Affairs</span></div><div><span style="font-family: Arial , sans-serif;">Commercial Operations</span></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">SUPERVISOR RESPONSIBILITY</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div><span style="font-family: Arial , sans-serif;">None</span></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div> </div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">SHIFT DETAILS</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><div><span style="font-family: Arial , sans-serif;">Shift will be 8 hours per day.<span>  </span>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. </span></div><div><span style="font-size: 10.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">ONSITE, REMOTE, OR FLEXIBLE</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><div><span style="font-family: Arial , sans-serif;">This role has the flexibility to be a remote position, covering both EU and US time zones.<span>  </span>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. </span></div><div><span> </span></div><div><b><u><span style="font-size: 10.5pt;font-family: Arial , sans-serif;color: black;">TRAVEL REQUIRED</span></u></b><u><span style="font-size: 9.0pt;font-family: Helvetica , sans-serif;color: black;"> </span></u></div><div><span style="font-size: 10.0pt;font-family: Arial , sans-serif;color: black;"> </span></div><div><span style="font-family: Arial , sans-serif;">May travel up to 25%+ of the time</span></div><div><span style="font-family: Arial , sans-serif;"> </span></div><div><span style="font-family: Arial , sans-serif;">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.</span></div><p><br /><br />Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. <br /><br />Equal Opportunity Employer/Veterans/Disabled <br /><br />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.</p>