Computer System Validation (CSV) Manager (m/f/d)

We are seeking an experienced and quality-driven Computer System Validation (CSV) Manager to lead validation activities across IT systems and applications within a regulated pharmaceutical environment. In this role, you will ensure that computerized systems meet compliance requirements in line with global regulations such as GxP, EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5.

You will play a key role in shaping our global validation strategy and act as a trusted partner to IT, Quality, and other cross-functional teams during system development, deployment, and maintenance phases.

Key Responsibilities

• Lead and manage validation activities for IT systems to ensure compliance with pharmaceutical regulatory requirements and internal quality standards.

• Support the design and implementation of a global IT validation strategy in line with GxP and other relevant regulatory guidelines.

• Create and maintain comprehensive lifecycle documentation, including validation/test plans, risk assessments, traceability matrices, and summary reports.

• Develop and review CSV policies, procedures, and validation documentation to ensure regulatory compliance and good documentation practices.

• Manage validation records and documentation across projects and systems in a structured and audit-ready manner.

• Conduct periodic reviews of validated systems and evaluate changes to assess re-validation needs.

• Schedule and lead cross-functional meetings with IT, Quality, and Business stakeholders to align on project scope, risks, and execution plans.

• Act as a subject matter expert during internal and external audits, supporting CSV-related discussions and documentation.

• Stay current on regulatory trends and industry best practices in computerized system validation; provide training and guidance across departments.

• Contribute to the continuous improvement of the validation process, tools, and templates to enhance efficiency and compliance.

Your Profile

• University degree in IT, engineering, natural sciences, or a related discipline.

• At least 4 years of experience in CSV, IT validation, quality assurance, or IT compliance, ideally within the pharmaceutical or medical device industry.

• Deep understanding of GxP requirements and regulatory frameworks such as EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5.

• Proven ability to manage validation projects across diverse systems and stakeholder groups.

• Experience with medical device regulatory frameworks (e.g., MDD, MPG, EU-MDR) is a plus.

• Strong analytical and problem-solving skills with a structured, detail-oriented approach.

• Excellent communication skills and the ability to operate confidently in international, cross-functional environments.

• Fluent English skills (written and spoken); German language skills are an advantage.

• Proficient in Microsoft Office and familiar with tools such as JIRA, ServiceNow, Solution Manager, or TrackWise.

Why Join Us?
This is an exciting opportunity to shape the quality and compliance standards of global IT systems in a regulated environment. You will work in a collaborative and international team, contributing directly to patient safety and data integrity in a dynamic, forward-thinking organization.