Mgr Quality Systems Data Integrity & Validation

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
People Leader

All Job Posting Locations:
Leiden, Netherlands

Job Description:

We are looking for a Manager Quality Systems Data Integrity & Validation to join our BioTherapeutics Quality Systems and Compliance team in Leiden, The Netherlands .

Primary focus

Quality oversight of Data Integrity, Validation, computerized systems compliance, system-related improvements, and digitalisation initiatives in a GxP environment.

Scope and Complexity

This role operates in a complex, highly regulated, multi-functional GxP environment.

The Manager Quality Systems must be able to interpret regulatory expectations, translate them into practical Quality System requirements, and drive compliant execution across technical and operational teams.

The role requires strong judgment, independent decision-making, and the ability to balance regulatory compliance, technical feasibility, business priorities, and patient safety.

The position has a significant impact on site inspection readiness, computerized systems compliance, Data Integrity maturity, and the successful implementation of digital and system improvement initiatives.

Role Purpose

The Manager Quality Systems is responsible for providing Quality oversight and leadership for Data Integrity, Validation, computerized systems compliance, and related Quality System improvements.

The role ensures that GxP systems, processes, and data governance activities are designed, implemented, maintained, and improved in compliance with applicable regulatory requirements, company standards, and industry expectations.

The position plays a key role in strengthening site compliance, inspection readiness, and the maturity of Quality Systems related to computerized systems, Data Integrity, validation lifecycle management, and digital transformation.

The Manager acts as a Quality subject matter expert and business partner for cross-functional teams, ensuring that technical, operational, and digital initiatives are implemented in a compliant, risk-based, and sustainable manner.

Principal Responsibilities

Quality Oversight of Data Integrity


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