Computer System Validation Lead

As a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications.

Responsibilities:

• Define overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with QA policies.
• Author key validation documents: Validation Plans, Validation Summary reports, Test Plans, etc.
• Advise project and technology teams on validation and data integrity best practices and approaches.
• Collaborate with GCP QA on process definition and improvement, author and revise CSV related SOPs.
• Coordinate with external Vendors on Validation and general IT operations support tasks.
• Coordinate CSV activities (UAT, document reviews) for clinical digital projects.
• Liaise with GMP CSV team to harmonize and streamline validation practices.
• Provide training on validation process and templates.
• Oversee CSV readiness for inspections and audits, support QA and business team during inspection activities.

Requirements:

• 10+ years of computerized system validation experience with a primary focus on GCP, GVP and GLP.
• 5+ years of validation team leadership providing coaching and mentoring to CSV engineers/tech writers and coordinating validation efforts within larger projects.
• Proven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure. Broad understanding of Technology implementation (SaaS) and Data migrations approaches.
• Working knowledge of CSV, data integrity and ICH guidance related to the use of computerized systems in clinical trials.
• Solid PM skills.
• Experience with Veeva platforms is a major plus.
• Extensive hands-on work with Validating GxP platforms such as RIM, QMS, SAS.
• High level experience with RIM processes.
• Experience supporting regulatory inspections related to computerized systems.
• Excellent communication skills.
• Demonstrated experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches.
• Experience with paperless validation preferred.
• Bachelor’s degree in computer science, biotechnology, engineering, or equivalent.