Computer System Validation Lead
4 weeks ago
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.
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