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Manager, Computer System ValidationAlimentiv • London, Ontario, Canada
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Manager, Computer System Validation

Alimentiv
  • CA
    London, Ontario, Canada
  • CA
    London, Ontario, Canada
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À propos

As Manager/Senior Manager, Computerized System Validation, you will lead the transformation of CSV practices within a dynamic contract research organization. Leveraging deep expertise in global regulatory requirements, including FDA, EMA, GCP, and ICH guidelines, you will ensure validation processes are risk-based, efficient, and compliant. You will be responsible for interpreting and applying these regulations pragmatically to both off-the-shelf and custom-developed software solutions, enabling agile software delivery while maintaining the highest standards of quality and compliance. This role requires a collaborative leader who partners effectively with Technology, Product, Quality, and operational teams, advocates for practical and common-sense solutions, and drives continuous improvement in technology and clinical research operations. Responsibilities
  • The Manager/Senior Manager, CSV will be responsible for the following:

    • Computerized System Validation Leadership
  • Develop, implement, and continuously refine risk-based CSV strategies for both off-the-shelf and custom-developed software, ensuring alignment with FDA, EMA, GCP, and ICH guidelines.
  • Oversee the full lifecycle of validation activities, including planning, execution, documentation, and maintenance, with a focus on integrating CSV into agile software development processes.
  • Ensure validation deliverables such as risk assessments, validation plans, protocols, test cases, and traceability matrices are prepared to the highest standards of quality and regulatory compliance.
  • Monitor and interpret changes in global regulatory requirements, proactively updating internal policies and procedures to maintain compliance and operational excellence.
  • Utilize technology to drive operational efficiencies into the CSV process.

    • Regulatory Compliance and Quality Assurance
  • Serve as the subject matter expert on regulatory requirements for computerized systems supporting clinical research, providing guidance on the practical application of regulations to diverse technology solutions.
  • Collaborate closely with Quality to identify, assess, and remediate compliance gaps, ensuring all systems meet GCP and other relevant standards.
  • Lead the preparation and submission of documentation for regulatory inspections, audits, and sponsor audits, ensuring timely and accurate responses to findings and observations.

    • Cross Functional Collaboration and Stakeholder Engagement
  • Act as a strategic partner to corporate IT, Product, software development, Quality, and operational teams, facilitating the integration of CSV requirements into business processes and technology projects.
  • Advocate for pragmatic, risk-based approaches that balance regulatory compliance with business agility and innovation.
  • Design and deliver training programs to build organizational capability in CSV principles, regulatory requirements, and best practices.

    • Team Management & Development
  • Lead, mentor, and develop a team of validation specialists, fostering a culture of collaboration, accountability, and continuous improvement.
  • Ensure the team is appropriately resourced, trained, and equipped to deliver on validation objectives and support organizational growth.
  • Conduct regular performance reviews, set clear goals, and provide constructive feedback to support professional development and high performance.

    • Audit & Inspection Support
  • Represent the CSV function during internal and external audits, regulatory inspections, and sponsor reviews.
  • Coordinate the investigation and resolution of audit findings, ensuring corrective and preventive actions are implemented effectively and sustainably.
  • Maintain readiness for audits by ensuring documentation, processes, and systems are consistently compliant and up to date.
    • Qualifications
  • 7-9 years minimum experience in Computerized System Validation in a CRO environment
  • Extensive experience in Computer System Validation (CSV) within GxP environments, ideally in a CRO, pharmaceutical, or biotech setting.
  • Deep knowledge of regulatory frameworks such as 21 CFR Part 11, GAMP 5, EU Annex 11, and data integrity principles.
  • Strong understanding of clinical trial processes, electronic systems (e.g., CTMS, eTMF, EDC), and their validation requirements.
  • Proven ability to lead validation projects, manage cross-functional teams, and oversee vendors or third-party system providers.
  • Excellent communication skills for translating technical requirements into clear guidance for non-technical stakeholders.
  • Advanced problem-solving and risk-assessment capabilities for determining appropriate validation scope and strategies.
  • Experience preparing for and supporting regulatory inspections, sponsor audits, and internal quality reviews.
  • Strong organizational and project-management skills, including the ability to manage multiple global initiatives simultaneously.
    • London, Ontario, Canada

    Compétences linguistiques

    • English
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