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CSV Lead / Manager
Job in
Boston, Suffolk County, Massachusetts, 02108, USA
Listed on 2026-08-18
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-08-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Title
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 and 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.
- 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.
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