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