Data Integrity and Governance Specialist

6 days ago

Vancouver, British Columbia, Canada AbCellera Full time
About the Role

We are seeking a skilled Data Integrity and Governance Manager to join our Digital Quality team at AbCellera. As a key member of our team, you will be responsible for driving the implementation of an effective GxP data integrity governance program across the entire product lifecycle.

Key Responsibilities:
  • Develop and execute DI plans, process mapping, gap assessments, and remediation planning
  • Facilitate the Data Integrity Community of Practice and serve as the DI Subject Matter Expert
  • Collaborate with data governance to ensure accountability for data assets supporting Health Authority Regulated activities
  • Promote cross-functional collaboration to develop a "DI by design" mindset and achieve sustainable DI compliance
  • Provide quality management with information on the performance of the data integrity governance program
  • Define roles and responsibilities for data integrity & governance in a HAR/GxP environment
  • Create and deliver cross-functional DI training and manage knowledge sharing
  • Develop and utilize metrics and KPIs to ensure DI program success
  • Support regulatory agency and third-party inspections
Requirements:
  • 5 years of industry experience in data management, data governance, or data integrity
  • Bachelor's degree in a scientific, mathematics, statistics, engineering, or business discipline
  • Working knowledge of industry best practices, including health authority regulation guidance and industry guidelines
  • Subject matter expertise in ERES, DI, and risk management requirements for Health Canada, EU EMA, FDA, MHRA regulatory environments
  • Technical familiarity with data architecture principles and design aspects of various data and analytics solutions
  • Outstanding communication, team player, and relationship builder skills
  • Lean Six Sigma training and accreditation
About AbCellera

AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

We look for people with drive and energy, idealists who are passionate about making a difference. If you are a motivated professional with a strong background in data integrity and governance, we encourage you to apply for this exciting opportunity.

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