דרושים Computer System Validation Lead ברחובות

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.