Associate Director - Quality, Data Governance and Technology
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- Nov 6, 2024
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- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
- 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.
- As needed, 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.
- Bachelor's or advanced degree (preferred) 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 group to achieve business objectives.
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.
Company
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 have developed eight important medicines for patients with significant unmet medical need. Our approved therapies treat achondroplasia, severe hemophilia A and several rare inherited and lysosomal storage diseases.
As we have looked to expand our impact, our approach to cutting-edge science has remained the same. 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. Our work is deeply rooted in genetic insights, meaning we target the underlying genetic changes or proximal molecular mechanisms of disease.
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.
- Website
- https://www.biomarin.com/
- Location
-
San Rafael and Novato
California
United States
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