Full-Time

Gxp Data Integrity & Governance Manager

Confirmed live in the last 24 hours

AbCellera Biologics

AbCellera Biologics

501-1,000 employees

Develops antibody-based medicines and technologies

AI & Machine Learning
Data & Analytics
Biotechnology

Compensation Overview

$85,200 - $106,500Annually

+ Equity + Annual Bonus + RRSP Contribution + Active Lifestyle Allowance + Vacation + Flexible Work Arrangements + Professional Development Opportunities + Comprehensive Health Benefits

Senior

Vancouver, BC, Canada

Required Skills
Data Analysis
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 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 communicator, team player, and relationship builder
  • Lean Six Sigma training and/or accreditation
Responsibilities
  • Providing hands-on development, execution, and coordination of activities related to data integrity governance program
  • Facilitating the data integrity and governance community of practice and supporting the design and development of data governance roadmap
  • Ensuring accountability for the stewardship and appropriate control of data assets supporting Health Authority Regulated activities
  • Program management of data integrity governance activities
  • Supporting maintenance and/or required Quality function verification on GxP master data in health authority regulated eSystems
  • Defining policy and internal standards to meet compliance obligations acting as the Quality Data Steward
  • Establishing procedures for the entry and maintenance of master data and metadata within health authority regulated eSystems
  • Identifying end-to-end business integration opportunities that leverage data and treat data as an enabling business asset

AbCellera distinguishes itself as an exemplary workplace within the biotechnology sector by expertly merging advanced technology and data science with an integrated team of experts. This strategic amalgamation not only speeds up the development of antibody-based medicines but also fosters an environment that is at the cutting edge of therapeutic innovation. By working here, one can directly contribute to solving complex challenges in drug development, benefiting from a collaborative culture that emphasizes efficiency and breakthroughs in healthcare solutions.

Company Stage

Series A

Total Funding

$393.1M

Headquarters

Vancouver, Canada

Founded

2012

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

13%

2 year growth

75%