Manager, Computer System Validation - Denver - Alimentiv

    Alimentiv
    Alimentiv Denver

    4 days ago

    Description

    Overview

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

    Responsibilities

    • 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.

    We may use artificial intelligence (AI) tools to support parts of the hiring process. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. + bonus


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