Principal Qualified Person

Who We Are 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. Director Product Quality Oversight & Release - Shanbally, Ringaskiddy Closing Date: 31st October 2025 Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard - so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. 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. Come join our team and make a meaningful impact on patients' lives. The Head of product Quality Oversight and Release (PQOR) is a highly motivated technically knowledgeable leader with proven abilities to direct quality assurance activities across multiple internal & external business partners for Technical Operations (TOPS). The successful candidate will strengthen the Quality culture and ensure the manufactured product meets all company and regulatory standards. This leader will develop a high performing team and provides leadership and guidance to the organization. By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for quality activities related to all commercial phases of production generated on behalf of Biomarin that is released for sale or export in Europe. These products span different platforms including biologics, devices, gene therapies, oligonucleotides, and small molecules The Head of PQOR is the primary QP.. The leader would champion continuous improvement to reduce variability in production and to maintain high quality product. This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. Accountabilities include lot disposition decisions as well as Health authority/ defect Head PQOR will build strong Quality to Quality relationships with the BioMarin Manufacturing Organization sites (External Operations, Shanbally manufacturing and Novato manufacturing) , to ensure effective communications and oversight of manufacturing operations. The incumbent is expected to work with cross functional disciplines to resolve issues, improve relevant business processes and systems. The Head of PQOR will report to the Shanbally Quality Site Head and is responsible for the Commercial Qualified Person & QP Certification team. This position will sit on the Shanbally Quality Leadership Team. SCOPE People Leader, with a team of ~15 people, all working to make quality product for patients. The responsibilities in the role include the following: Assures quality products and processes by establishing and enforcing quality systems and standards. Stay current with relevant regulatory guidelines, ensuring the company wide promotion and adherence to applicable regulatory and quality requirements QA representation during site health authority inspections, and business forums including MRB, GIM and site leadership teams. Build, lead and mentor a high performing quality team, setting clear objectives and guidance to ensure quality goals are met Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management. Implement risk assessment processes to proactively identify, mitigate and manage quality risks Collaborate with cross functional teams to address quality issues. Drive a culture of continuous improvement, implementing best practices and quality initiatives. Participates in the Quality AOP, Forecast and Long-Range financial budgeting process and ensures adherence to budget. Provide technical direction and leadership to direct the quality review of product documentation, including deviations, investigations CAPAs (Corrective and Preventive Actions) and HA (Health Authorities) observations. Accountable for Quality and Compliance decisions, including product disposition decisions as per cGMP's. Provide strategic direction to the QP department to ensure that QA specific corporate objectives are met, including improving internal processes and practices. Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additionala plus). Ensure Quality staff training and development Education, Skills and Experience At least 10 years of experience in quality assurance or control roles within the biopharmaceutical or pharmaceutical sectors. Established Qualified Person (QP) certification under EU regulations, complemented by no fewer than 5 years serving as a designated QP in a licensed MIA/IMP manufacturing facility. Comprehensive expertise in HPRA, EU, FDA, and GMP guidelines and regulatory frameworks. Proven track record in managing aseptic and/or biotechnology products and processes, including oversight of finished product packaging operations. Exceptional leadership and interpersonal communication abilities, demonstrated through effective cross-functional influence and collaboration, with a minimum of 5 years in team leadership roles. Experience in multi-site quality management systems This position will interact with other departments throughout the position will partner with and influence Quality, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as position requires constant contact with Senior Management across the organization. Note:This description is not intended to be all-inclusive, or a limitation of the duties of the is intended to describe the general nature of the job that may include other duties as assumed or assigned. 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. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.