CSV Lead / Manager

CSV Lead / Manager Katalyst Healthcares & Life Sciences - 4.0 Waltham, MA Job Details Contract 20 hours ago Qualifications GxP Compliance audits & assessments Gap analysis 11+ years Team management Senior level SaaS FDA regulations Engineering validation

Full Job Description Job Summary:

Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. The role focuses on driving validation strategy, closing compliance gaps, supporting audit readiness, and overseeing validation activities across multiple enterprise systems while leading a team.

Roles & Responsibilities:

Lead and enhance the Validation / CSV program. Assess gaps in current validation processes and drive remediation roadmap. Prepare for FDA audits and support inspection readiness activities. Oversee validation activities across systems including Veeva, TMF, Argus, and Serialization platforms. Lead and manage a small team executing CSV activities. Operate at both strategic and execution levels to ensure effective validation and compliance.

Experience:

12+ years of experience in GxP CSV / Validation. Strong experience in FDA audit support and inspection readiness. Hands-on experience with SaaS validation platforms (e.g., Veeva). Ability to work at both strategic and execution levels.