Associate Director - Quality, Data Governance and Technology

Biomarin Pharmaceutical - Novato, CA

Full-time

Novato, CA

Wholesale Trade Agents and Brokers

About the position

The Associate Director Quality, Global QMS - Data Governance/Integrity Lead at BioMarin is responsible for owning and continuously improving the Data Governance program. This role involves cross-functional collaboration to ensure compliance and efficiency in data governance and integrity processes, supporting the overall business needs of the organization. The position requires strong leadership, technical expertise, and a deep understanding of data governance, data integrity, and quality management systems.

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 structure, leading and partnering with a matrix team of Business Process Managers responsible for establishing, owning, and continuously improving the process within their respective sites/functions.
• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Establish global KPIs and oversee trending of key performance metrics associated with the data governance process.
• Support Quality Management Review activities.
• Report and escalate compliance issues to management.
• Partner with Compliance on site Quality inspections within BioMarin with the goal of compliance to regulations and site harmonization.
• Provide SME support to site inspections, global inspections, and related observation responses.

Requirements

• Bachelor's or advanced degree in Data Science, Computer Science, Engineering (Chemical Engineering, Biotechnology, or a related field) or Life Sciences.
• 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry.
• Extensive knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
• Strong knowledge about data integrity, data governance, computer system validation and other related processes.
• Strong communication and stakeholder management skills with experience driving cross-functional initiatives.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
• Ability to present data and defend approaches in front of senior management and inspectors.
• Demonstrated ability to partner with other functional groups to achieve business objectives.