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.
