Computer System Validation Lead – Clinical Informatics

Domain: HealthTech, HighTech
Career Path: RTech, DataBridge, AgileData, Connect
Type: Full Time preferred

Seniority: Mid senior level
Location: Boston

Skills

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

Demonstrable 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

Education

Bachelor’s degree in computer science, biotechnology engineering or equivalent

Experience

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 project

Description

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.

Essential Duties & 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

Computer System Validation Lead – Clinical Informatics

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Arrayo is an Equal Employment Opportunity employer and as such does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.