סקירה כללית
^^משרה זו נלקחה מ Career^^Description 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 None
דרישות המשרה
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 t
