QA and Computerized System Validation

4 hours ago

Rehovot, Central District, Israel Dot Compliance Full time ₪100,000 - ₪120,000 per year

Dot Compliance is a cloud-based, innovative software company, and our product allows life science customers to manage their quality and compliance processes electronically. 

Our ideal candidate should be passionate about applying their validation expertise in a modern SaaS setting to influence strategy, build client trust, and grow professionally. You will succeed in this role if you are a detail-oriented advisor who thrives in a fast-paced, collaborative environment. The candidate will also develop experience in other professional service roles. 

Responsibilities: 

  • Lead the planning, development, and execution of validation deliverables (e.g., Validation Plans, Requirements Specifications, Test Scripts, Traceability Matrices, Summary Reports) for client implementations. 
  • Partner with clients to define validation scope and approach aligned with regulatory requirements and frameworks (e.g., FDA 21 CFR Part 11, Annex 11, GxPs, GAMP 5). 
  • Guide cross-functional teams to ensure validation activities are delivered on time and within project scope. 
  • Serve as the primary point of contact for validation and compliance questions during client implementations. 
  • Utilize AI-based tools to assist in generating and optimizing validation deliverables. 
  • Develop and maintain validation templates, processes, and best practices for Professional Services engagements. 
  • Develop and maintain validation documentation, including Validation Plans, Risk Assessments, URS, PQ Protocols, Traceability Matrices, and Validation Summary Reports 
  • Train and mentor internal team members and client stakeholders on validation processes and regulatory expectations. 
  • Identify opportunities for continuous improvement in validation methodologies and execution efficiency. 
Requirements
  • Bachelor's degree in computer science, Life Sciences, Engineering, or related field. 
  • 5+ years of experience in Computer System Validation (CSV), Quality, or Compliance roles, ideally within SaaS or cloud-based solutions. 
  • Strong knowledge of regulatory requirements (FDA 21 CFR Part 11, Annex 11, GxPs) and industry frameworks (GAMP 5). 
  • Proven track record leading validation efforts for enterprise software or SaaS implementations. 
  • Excellent written and oral communication skills - Hebrew and English 
  • Excellent communication, client-facing, and project leadership skills. 
  • Familiarity with risk-based validation and modern approaches to cloud/SaaS compliance. 
A+ if you meet these requirements
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