Director, Quality Data Governance & Technology

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 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. 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 Operations 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.

DESCRIPTION: The Director Quality, Data Governance & Technology is a senior Quality leadership role accountable for enterprise-wide Quality oversight of Computer System Validation (CSV) activities across BioMarin’s IT systems and applications, and for owning and continuously improving the CSV program in collaboration with the DTA (Digital Technology and AI) team. This role is equally accountable for leading BioMarin’s Data Governance and Data Integrity program, driving the design, effectiveness, and continuous improvement of data governance measures, global compliance and process performance. Cross-functional collaboration with partners and stakeholders across sites and functions is key to success in this role. This includes close partnership with data experts and stakeholders across engineering, computer system validation, manufacturing, data sciences, QC, QA, Compliance, and DTA. In collaboration with these SMEs and stakeholders, the Director ensures that all processes impacting computer software validation, data governance, and data integrity are compliant, agile, and support the evolving needs of the business. This role is also a driving force behind BioMarin’s digital and AI advancement within Quality. The Director partners with DTA, Data Science, and business stakeholders to identify, evaluate, and scale emerging technologies, including AI, machine learning, automation, and advanced analytics, ensuring BioMarin remains at the forefront of regulatory expectations while unlocking potential across the Quality organization. This is an exciting time to step into this role, as AI rapidly reshapes how Quality Processes can operate, the Director will have the opportunity to shape how BioMarin harnesses these technologies responsibly, positioning the organization at the leading edge of this transformation. This position requires in-depth knowledge and experience with computer system validation, data governance, and data integrity, along with a high-level understanding of other quality management system processes. The leader must possess strong leadership qualities, business acumen, and technical expertise in the areas of responsibility, together with a solid understanding of developments in data science and emerging