Computer Systems Validation (CSV) Lead

Computer Systems Validation (CSV) Lead – Vancouver – 12-Months/Remote

Are you ready to be part of a transformative journey in drug discovery? Our client 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. They are expanding their capabilities to include Process Development and Clinical Manufacturing of antibodies to bring therapies from idea to patients, faster.

If you're passionate about pioneering advancements in the biotech industry and making a tangible impact on patients' lives, this opportunity is tailor-made for you. Join us in this exhilarating journey towards a brighter future in healthcare.

Responsibilities

• 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)
• 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 10+ 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)
• Experience with vendor audits, system level agreements and quality agreements

If this role is of interest to you, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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