Jobs and Careers

Associate Director - Quality, Data Governance and Technology

United Statesfull_timeVerifiedPosted 5 Nov 2024

About the role

Who We Are

BioMarin 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 our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

SUMMARY DESCRIPTION The Associate Director Quality, Global QMS – Data Governance/Integrity Lead will be responsible for owning and continuously improving the Data Governance program at BioMarin. As Business Process Owner (BPO), they are accountable for the design and overall efficiency / effectiveness of the data governance/ data integrity program, along with driving global compliance and process performance. Cross functional collaboration with partners and stakeholders across different sites and functions is key for success in this role. This includes collaboration with data experts at the sites/functions and stakeholders from different departments like engineering, computer system validation, manufacturing, data sciences, QC, QA, Compliance and IT. In collaboration with the SMEs and stakeholders, the Associate Director QMS will ensure that all processes impacting data governance/data integrity are compliant, agile and support the business needs of the operation. This position requires in depth knowledge and experience with data governance, data integrity, computer system validation activities, and 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. They will also have a good understanding of developments in data science and the use of current and emerging technologies, such as AI, machine learning, and cloud computing, to address complex challenges in a pharmaceutical environment. RESPONSIBILITIES

Develop, establish, and maintain a comprehensive and compliant data governance program for BioMarin.
Define and implement data governance framework under a data governance master plan in collaboration with cross-functional teams, including IT, manufacturing, technical development, quality assurance, and R&D. Align and gain sponsorship from leadership and stakeholders.
Define deliverables for the implementation of enhanced data governance measures to enable data integrity assurance by-design. Ensure solutions are purposefully integrated into business processes to drive adoption.
Optimize data management and data integrity policy, procedures and programs to include standardizing methodologies and requirements within a harmonized and simplified QMS environment
Influence and participate in establishment of digital strategy and ensure BioMarin is at the forefront of regulatory expectations, guidance, and standards applicable to emerging technologies
Partner with IT, data sciences teams and other stakeholders to identify future technologies to support strategic business objectives
Implement training program for data governance/data integrity at BioMarin
Establish governance struct