IT System Validation Manager

Responsibilities

• Act as the Computer System Validation (CSV) project lead, responsible for validation strategies and management of IT systems in scope, primarily SAP S4HANA.
• Prepare and review CSV documentation in accordance with standard operating procedures, laws, and regulatory guidelines.
• Ensure IT systems operate in compliance with the company QMS and relevant frameworks, including pharma GxP, US FDA 21 CFR Part 11, EU GMP Annex 11, and US SOX Section 404.
• Contribute to change management, deviation resolution, and CAPA processes in coordination with IT, QA, and business stakeholders.
• Serve as an SAP ERP compliance subject matter expert (SME) during internal audits, supplier audits, and health authority inspections.

Requirements

• 8+ years of professional experience in a relevant field with a higher education degree.
• Proven track record of CSV and compliance expertise within GxP regulated industries (ideally pharmaceutical).
• Deep knowledge of US, EU, and China GxP regulations.
• Fluency in both English and Mandarin is required.
• Strong analytical and documentation skills with the ability to synthesize complex information.
• Excellent stakeholder management skills and the ability to interact confidently with auditors and cross-functional teams.

About the Company

BioNTech is a leading biotechnology company dedicated to developing next-generation therapeutics and vaccines. We value the well-being of every team member and provide a diverse, inclusive environment with competitive compensation and comprehensive benefits.