GxP Data Integrity & Governance Manager

AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who 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, you will ensure that the Health Authority Regulatory expectations, for all related systems and data across the organization, are met thoroughly, effectively, and efficiently.

How you might spend your days:

• Providing hands-on development, execution and coordination of activities related to our data integrity (DI) governance program including developing DI plans, process mapping, performing gap assessment or remediation planning, and performing control processes
• Facilitating the Data Integrity Community of Practice and serving as the DI Subject Matter Expert (SME)
• Working with the data governance function to ensure accountability for the stewardship and appropriate control of data assets supporting Health Authority Regulated (HAR) activities
• Promoting cross-functional collaboration to develop a “DI by design” mindset and achieve sustainable DI compliance
• Providing the quality management team with information on the performance of the data integrity governance program
• Defining roles and responsibilities for data integrity & governance supporting data management and usage in a HAR / GxP environment
• Creating and delivering cross-functional DI training and managing knowledge sharing. Additionally, develop and utilize metrics and KPIs to ensure the success of DI programs
• Offering support during regulatory agency and third-party inspections

We’d love to hear from you if:

• You have 5 years of industry experience in data management, data governance, or data integrity with a proven record of successfully implementing DI Governance programs (or equivalent)
• You have a bachelor’s degree in a scientific, mathematics, statistics, engineering, or business discipline
• You have 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
• You have subject matter expertise in ERES, DI, and risk management requirements for Health Canada, EU EMA, FDA, MHRA regulatory environments (this would be a strong asset)
• You have technical familiarity with data architecture principles and design aspects of various data and analytics solutions
• You are an outstanding communicator, team player, and relationship builder
• You continue to be inspired by working with teammates and partners to bring innovative medicines to patients, and are known for your attention to detail, timelines and creative thinking
• You have Lean Six Sigma training and/or accreditation (this would be a strong asset)

What we offer

AbCellera’s hiring range for this role is CAD $96,900 – $121,200 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. 

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find we prioritize teams and social groups to build community and connections across AbCellera.

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.

And it all starts with our team. We’ve built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

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.