Computer Systems Validation (CSV) Manager
AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 600 AbCellerites and growing, we’re expanding our capabilities to include Process Development and Clinical Manufacturing of antibodies to bring therapies from idea to patients, faster.
The Computer Systems Validation (CSV) Manager for both Enterprise Quality Systems and QC Lab will be responsible to lead, guide, and support cross-functional teams in the adoption and application of risk-based Computer Systems Validation/Computer Software Assurance practices to enable an interconnected/interoperable and GxP compliant digital ecosystem at AbCellera. This role is hands-on, highly cross-functional, and will work closely with IT to support the implementation and operation of multiple IT systems including those supporting R&D, Manufacturing, Quality Control and Quality Systems.
We’d love to hear from you if:
You are a passionate leader and critical thinker with the ability to motivate, inspire, and contribute to highly effective teams
You are comfortable operating in an evolving, complex, and dynamic environment, and driving against the deliverables of a digital roadmap
You are an independent contributor to the design, development, and implementation of the CSV/CSA program, to include developing and/or supporting procedures, guidance, and best practices
How you might spend your days:
Leading, coaching/mentoring, training, and developing cross-functional teams responsible for innovative, risk-based validation of Enterprise and QC impacting computerized systems
Overseeing and participating in validation planning and/or the execution of qualification and validation activities for new software system implementations
Creating and improving computer system validation related policies, procedures, guidance, templates, forms, etc.
Leading and guiding GxP applicability and system assessments tailored for the computerized system’s intended use
Authoring, reviewing and approving qualification and validation documentation (URS/specifications, testing and qualification protocols (IQOQPQ)/UAT), risk assessments, reports)
Leading and supporting data governance and data integrity compliance for computerized systems including FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures, EU-PIC/S-Health Canada Annex 11 - Computerised Systems, EMA - Guideline on computerised systems and electronic data in clinical trials, and other evolving GxP Data Integrity requirements and guidance
Working closely with vendors and system integrators to review and providing feedback on vendor deliverables (validation plans, risk assessments, qualification protocols, etc.), including making decisions to accept and leverage vendor documentation as part of validation strategies
Working closely with business functions and IT to provide expertise in CSV/CSA strategies, manage identified issues, and support continuous improvement
Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations in a true Quality by Design environment
Reviewing and approving computer system related change controls, discrepancies, deviations and CAPAs
Supporting inspection readiness programs and/or directly supporting regulatory agency inspections. Assisting in the coordination/content of responses to any findings as applicable
Required qualifications and experience:
Bachelor's degree in Information Systems, Engineering or similar technical discipline required
Minimum 8+ years of experience working in the Biotech/Pharmaceutical industry or related Life-Science industries in Quality Compliance or Computerized System Validation / Computer Software Assurance roles
Strong knowledge of Good Automated Manufacturing Practices (GAMP) principles and Computer Software Assurance for Production and Quality System
Strong knowledge in 21 CFR Part 11, Annex 11, and applicable data integrity requirements, standards, and guidelines
Strong background and understanding of Health Canada, EU, and FDA regulations
Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
Experience in authoring/reviewing/approving validation documentation
Working knowledge of the software development lifecycle (SDLC)
Experience supporting enterprise software deployments and laboratory/manufacturing equipment and instruments (such as LIMS, QMS, DMS, LMS)
Excellent written and verbal communication skills with ability to work with cross-functional teams
Experience with vendor audits, system level agreements and quality agreements
Ability to manage multiple, complex projects
What we offer
A generous compensation package including an equity stake in AbCellera’s success. Our headquarters are nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. 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. We’re looking for someone like you to support and organize our efforts along the way.