Data Governance Specialist

6 days ago


Vancouver, British Columbia, Canada AbCellera Full time

About the Role

AbCellera is seeking a highly skilled Data Governance Specialist to join our Digital Quality team. This role will work closely with GxP operational subject matter experts, the Information Technology team, and cross-functional system analysts and developers to define, design, and execute data governance processes that address health authority regulated compliance expectations for all related systems and data across AbCellera.

The ideal candidate will have 5 years of industry experience in data management, data governance, or data integrity with a proven record of successfully implementing DI Governance programs. They will possess a working knowledge of industry best practice including health authority regulation guidance and industry guidelines (PICs / ISPE GAMP etc.) for data integrity, data governance, and data management within a life science environment.

Key Responsibilities

  • Providing hands-on development, execution and coordination of activities related to our data integrity (DI) governance program.
  • Facilitating the data integrity and governance community of practice and supporting the design and development of AbCellera's data governance roadmap.
  • Working with the data governance function to ensure accountability for the stewardship and appropriate control of data assets supporting Health Authority Regulated activities.

Requirements

  • A bachelor's degree in a scientific, mathematics, statistics, engineering, or business discipline.
  • A working knowledge of industry best practice including health authority regulation guidance and industry guidelines (PICs / ISPE GAMP etc.) for data integrity, data governance, and data management within a life science environment.
  • Subject matter expertise in ERES, DI, and risk management requirements for Health Canada, EU EMA, FDA, MHRA regulatory environments.


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