Full Description

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