Validation Manager for Holistic Data Management Project | 100% remote | Pharma

📍 Hybrid | Pharmaceutical Industry Are you passionate about Computer System Validation (CSV) and ensuring compliance in regulated environments? We are looking for a Validation Manager to lead validation activities for a strategic Holistic Data Management (HDM) initiative within a global pharmaceutical environment. 🚀 What You'll Do As Validation Manager, you will be responsible for ensuring that the system meets all applicable validation and compliance requirements throughout its lifecycle. Key responsibilities include: - Own and coordinate all validation activities for the system. - Prepare, review, and maintain validation documentation, including Validation Plans, Test Documentation, Traceability Matrices, Validation Summary Reports, and related records. - Lead qualification activities across QA and Production environments, ensuring release readiness. - Coordinate validation testing activities, deviation management, and defect resolution. - Ensure compliance with CSV, GxP, GLP, and applicable validation standards. - Review and support SOPs, AAPs, training materials, and operational documentation required for go-live. - Collaborate with Business stakeholders, IT System Leads, Quality Assurance, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities. - Act as a key compliance partner during audits, inspections, and system lifecycle activities. ✅ Must-Have Requirements - Bachelor's degree in Information Technology, Healthcare, Life Sciences, or a related field. - Strong knowledge of Computer System Validation (CSV) principles and methodologies. - Expert understanding of regulatory frameworks and guidance, including: - FDA 21 CFR Part 11 - EU GMP Annex 11 - GxP requirements and validation best practices - Experience preparing and maintaining validation documentation in regulated environments. - Solid understanding of validated IT systems, including software, infrastructure, and system integrations. - Strong analytical, documentation, and stakeholder management skills. ⭐ Nice to Have - More than 3 years of experience in Computer System Validation within the pharmaceutical, biotechnology, or life sciences industry. - Experience supporting complex data management, digital transformation, or enterprise applications. - Previous exposure to audit and inspection readiness activities. - Experience working within global, cross-functional teams. SCHEDULE 🕘: - 08h-17h from Monday to Friday (flexible) - Full remote CONDITIONS 🌱: - Salary package based on your profile. - Permanent contract - Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check. - Discounts in gym network. - Training catalogue. - Referral program Our goal is that you are well in every way! Originally posted on Himalayas