Data Integrity Governance Manager

4 weeks ago

Vancouver, British Columbia, Canada AbCellera Full time

At AbCellera, we are breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. Our team of scientists, engineers, creatives, and business professionals believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.

We are seeking a Data Integrity and Governance Manager to join our Digital Quality team where you will drive the implementation of an effective GxP data integrity governance program across the entire product lifecycle (discovery, development, clinical manufacturing, and supply chain operations). In this role, based in Vancouver, you will ensure that the Health Authority Regulatory expectations, for all related systems and data across the organization, are met thoroughly, effectively, and efficiently.

Key Responsibilities:

  • Develop and execute data integrity plans, process mapping, and gap assessments to ensure compliance with regulatory requirements.
  • Facilitate the Data Integrity Community of Practice and serve as the DI Subject Matter Expert (SME).
  • Collaborate with the data governance function to ensure accountability for data stewardship and control.
  • Promote cross-functional collaboration to develop a "DI by design" mindset and achieve sustainable DI compliance.
  • Provide quality management team with information on the performance of the data integrity governance program.
  • Define roles and responsibilities for data integrity & governance supporting data management and usage in a HAR / GxP environment.
  • Create and deliver cross-functional DI training and manage knowledge sharing.
  • Offer support during regulatory agency and third-party inspections.

Requirements:

  • 5 years of industry experience in data management, data governance, or data integrity with a proven record of successfully implementing DI Governance programs.
  • Bachelor's degree in a scientific, mathematics, statistics, engineering, or business discipline.
  • 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.
  • 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/or 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. People we love and people we trust. This may be unconventional, but it is the key to our success.

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