Director, Quality Data Governance &… at BioMarin… · San Rafael

Who We Are

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.

SUMMARY 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 technologies such as AI, machine learning, and cloud computing, to address complex challenges in a pharmaceutical environment.

RESPONSIBILITIES:

Computer System Validation (CSV) Quality Oversight & Program Leadership

• Provide leadership and direction to a team of Quality Engineers responsible for Quality oversight of computer software validation activities for enterprise-wide systems and applications. Ensure appropriate resource support to manage established portfolio of projects.
• Co-lead continuous improvement of the CSV program, standardizing methodologies, requirements, and lifecycle approach within a harmonized and simplified QMS environment.
• Evolve the CSV program's execution model to be ready for a future where AI plays an increasing role in system validation, reassessing methodologies, controls, and resourcing so the program can efficiently and compliantly validate AI-enabled systems and leverage AI-assisted validation tools as they mature.
• Ensure CSV/CSA activities are interconnected, aligned, and streamlined with policies and procedures established by DTA and CSV, applying a System Development Lifecycle approach commensurate with system complexity, risk, and intended use.
• Establish global KPIs and oversee trending of key performance metrics associated with the CSV program; support Quality Management Review activities; report and escalate compliance issues to management.
• Partner with Compliance on site and global Quality inspections, providing SME support related to CSV activities and related observation responses.

Data Governance & Data Integrity Program Leadership

• Develop, own, and continuously improve a comprehensive and compliant Data Governance / Data Integrity program for BioMarin, accountable for its design and overall effectiveness.
• Implement the 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, ensuring solutions are purposefully integrated into business processes to drive adoption.
• Optimize policies, procedures, and programs for data governance and data integrity, standardizing methodologies and requirements within a harmonized and simplified QMS environment.
• Implement and maintain a training program for data governance / data integrity across BioMarin.
• Establish and lead a governance structure, partnering with a matrix team of site and functional representatives accountable for establishing, owning, and continuously improving data governance processes within their respective areas.

Establish global KPIs and oversee trending of key performance metrics associated with the data governance / data integrity program; support Quality Management Review activities; report and escalate compliance issues to management.

Digital Transformation, Data & Artificial Intelligence

• Support the establishment of BioMarin’s digital and AI strategy for Quality, ensuring the organization is at the forefront of regulatory expectations, guidance, and standards applicable to emerging technologies.
• Partner with IT, Data Science teams, and other stakeholders to identify, evaluate, and pilot future technologies, including AI, machine learning, automation, and advanced analytics, to support strategic Quality and business objectives.
• Drive the effective use of Quality data by integrating information from QMS and other enterprise systems to generate actionable insights and enable data-driven decision-making.

Champion the responsible piloting and scaled deployment of AI-enabled tools within Quality, ensuring appropriate governance, human-in-the-loop controls, and evidence-based, measurable KPIs guide go / no-go decisions.

Cross-Functional & Network Collaboration

• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Collaborate with data experts and stakeholders across engineering, manufacturing, data sciences, QC, QA, Compliance, and IT to ensure processes remain compliant, agile, and aligned to business needs.

As needed, partner with Compliance on site Quality inspections with the goal of regulatory compliance and site harmonization; provide SME support to site and global inspections and related observation responses.

Leadership, Talent & Organization Development

• Lead, coach, and develop a high-performing team of Quality Engineers, building capability in CSV, data governance, and digital / AI competencies.
• Foster a culture of continuous improvement, compliance, and innovation across the CSV and data governance functions.
• Drive a consistent, standardized approach to CSV and data governance across the global network while enabling flexibility where required.

EDUCATION:

• Bachelor’s or advanced degree (preferred) in Data Science, Computer Science, Engineering (Chemical Engineering, Biotechnology, or a related field), or Life Sciences.

EXPERIENCE:

• 15+ years of experience in Biotechnology, Pharmaceutical, Medical Device, or another highly regulated industry.
• Extensive knowledge and experience with GMP and GDP global regulations, principles, concepts, practices, and standards.
• Strong knowledge of computer system validation, data integrity, data governance, and related processes.
• 8+ years of prior management-level experience with a demonstrated ability to develop and mentor staff.
• Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions is a strong plus.
• Strong communication and stakeholder management skills, with experience driving cross-functional initiatives.
• In-depth experience managing teams, and providing coaching, development, and mentoring to employees.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Excellent interpersonal and communication skills, with the 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.

WORKSTYLE:

• Preference for the individual to have an onsite presence at Headquarters in San Rafael, CA. However open to virtually based employees.

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.

Equal Opportunity Employer/Veterans/Disabled

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.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.