Arrayo
Computer System Validation Lead
Arrayo, Boston, Massachusetts, us, 02298
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr