Manager, CSV, Manufacturing Systems
AbCellera is transforming antibody drug discovery to bring better medicines to patients more quickly. We are constructing a process development and manufacturing facility in Vancouver, Canada, where our Tech Ops team of scientists and engineers will oversee the manufacturing processes for antibody therapeutics.
The Computer Systems Validation (CSV) Manager for both Enterprise level and Manufacturing Computer Systems is an innovative role within AbCellera Digital Quality. This is a role responsible to lead, guide and support cross-functional teams in the adoption and application of risk-based Computer Software 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 and business stakeholders to support the validation of multiple systems including those supporting R&D, Manufacturing, Quality Control and Quality.
AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be 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!
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 and practices.
- You have strong, hands-on experience with the System Development Lifecycle and the principles of GAMP 5, A Risk-Based Approach to Computer System Validation, 2nd Edition; and the oversight, participation, and execution of risk-based validation activities for QC impacting systems.
- You are enthusiastic about adopting innovative, risk-based strategies for validating Enterprise and Manufacturing impacting systems based on intended, while enabling agile, sustainable compliance.
- You are self-motivated, independent and excel within cross functional teams including IT, Engineering, Manufacturing, Quality Assurance, and additional GxP business process owners.
How you might spend your days
- Leading, coaching, mentoring, training and developing cross-functional teams for validation of computerized systems.
- Overseeing and/or participating in validation planning and execution of new software/automation implementations.
- Creating and/or improving computer system validation policies, procedures, templates, and forms.
- Leading and guiding GxP applicability and system assessments tailored for computerized systems.
- Authoring, reviewing and approving qualification/validation documentation and reports.
- Supporting data governance and integrity compliance for computerized systems.
- Reviewing and approving computer system related change controls, discrepancies, deviations, and CAPAs.
- Working closely with vendors to review and provide feedback on vendor validation documentation.
- Providing expertise in CSV compliance, manage identified issues, and support continuous improvement.
- Supporting inspection readiness programs and regulatory agency inspections.
- Developing and evaluating quality processes and system standards to ensure compliance with regulations and standards.
Required Qualifications and Experience
- Bachelor's degree in information systems, engineering, or similar technical discipline.
- Minimum 8+ years of experience in Quality Compliance or Computer System Validation roles in Biotech/Pharmaceutical industry.
- Strong knowledge of GAMP principles and Computer Software Assurance.
- Strong knowledge in 21 CFR Part 11, Annex 11, and applicable data integrity requirements.
- Strong understanding of Health Canada, EU, and FDA regulations.
- Knowledge of GCP, GVP, GMP, GDP, and GLP.
- Experience in authoring/reviewing/approving validation documentation.
- Working knowledge of SDLC.
- Experience supporting enterprise software deployments and manufacturing equipment and instruments.
- Experience with vendor audits, system level agreements, and quality agreements.
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