Associate Director - Quality, Data Governance and Technology

Location:  Novato, California Category: Quality

Hiring Manager: Stijn Goudeseune ([email protected])

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Description

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

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