CVS Lead

CVS Lead at Katalyst CRO

The CVS Lead is responsible for leading Computer System Validation activities for GxP-regulated systems to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordinating with cross‑functional teams, and ensuring audit readiness.

• Lead Computer System Validation (CSV) activities across multiple GxP systems
• Own and manage CSV lifecycle (Plan, Requirements, Risk Assessment, IQ, OQ, PQ)
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5
• Review and approve validation deliverables
  • Validation Plans (VP)
  • User Requirement Specifications (URS)
  • Functional & Design Specifications (FS/DS)
  • Risk Assessments
  • Test Scripts & Traceability Matrix
• Provide CSV governance for
  • ERP (SAP)
  • LIMS, MES, QMS
  • Laboratory instruments & interfaces
• Lead and support regulatory audits & inspections (FDA, EMA, MHRA)
• Manage change control, deviation, CAPA related to validated systems
• Mentor and guide CSV analysts and validation teams
• Coordinate with IT, QA, vendors, and business stakeholders
• Drive data integrity (ALCOA+) compliance
• Ensure periodic reviews and system retirement activities

• Bachelor's/Master's in Engineering, Computer Science, Pharmacy, or Life Sciences
• 8+ years of experience in Computer System Validation
• Strong knowledge of
  • GxP regulations
  • GAMP 5
  • SDLC & Agile validation
  • Risk-based validation approaches
• Hands‑on experience with validation of cloud‑based systems
• Excellent documentation and audit handling skills
• Strong leadership and stakeholder management abilities Preferred Skills
  • Experience with SAP S/4
    
    HANA validation
  • Exposure to Agile / Dev Ops CSV
  • Knowledge of Data Integrity & Cybersecurity
  • Certification in CSV / GMP / Quality Systems
  Tools & Technologies
  • SAP, LIMS, MES, Track Wise, Veeva, Lab Ware
  • JIRA, Confluence
  • Validation tools (Client ALM, qTest)
  Seniority Level

  Mid‑Senior level

  Employment Type

  Contract

  Job Function & Industries
  • Other
  • Pharmaceutical Manufacturing

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