IT CSV & CQV Validation Lead

IT CSV & CQV Validation Lead – Katalyst CRO Responsibilities

• Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials.
• Ensure all documentation complies with regulatory standards such as FDA, EMA, GxP, and other relevant guidelines.
• Review and approve validation documents to confirm alignment with project objectives and regulatory requirements.
• Lead and oversee multiple quality and validation projects, clearly communicating goals, timelines, and key milestones.
• Proactively identify potential risks and implement mitigation strategies to ensure timely and successful project delivery.
• Collaborate with internal teams and external stakeholders to ensure alignment on deliverables and expectations.
• Conduct regular project status meetings and prepare progress reports for stakeholders.
• Ensure all validation activities and documentation adhere to industry best practices and regulatory requirements.
• Provide support during internal and external audits by offering expertise in validation and quality assurance.
• Serve as a subject matter expert in quality systems, validation methodologies, and regulatory compliance.

• IT CSV Validation of IT systems.
• CQV Qualification of Equipment.
• Knowledge of regulatory frameworks (e.g., FDA 21 CFR Parts 11, 211, 820; industry standards such as ISPE, GAMP
  5).
• Experience with Veeva Quality Docs, Service Now, JIRA, and Kneat.
• Pharma industry experience is mandatory.
• Experience in authoring validation documents and managing validation projects.
• Demonstrated ability to lead and oversee multiple quality and validation projects.

• Associate

• Contract

• Information Technology

• Pharmaceutical Manufacturing