Alimentiv · 6 hours ago
Manager, Computer System Validation (CSV)
United States
Full-time
Remote
Senior Level
$98K/yr - $163K/yr
7+ years expAlimentiv is a dynamic contract research organization seeking a Manager/Senior Manager for Computerized System Validation. The role involves leading the transformation of CSV practices, ensuring compliance with global regulatory requirements, and collaborating with various teams to drive operational efficiencies and quality in technology and clinical research operations.
BiotechnologyClinical TrialsConsultingHealth CarePharmaceuticalPrecision Medicine
Responsibilities
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
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
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
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
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
Qualification
Required
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
Benefits
+ bonus
Company
Alimentiv
Industry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Pierre Gaudreault
Chief Executive Officer, Alimentiv
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