Senior Quality Systems Engineer

We are seeking an experienced Senior Quality Systems Engineer to support a strategic project for within our Manufacturing & process unit. The consultant will lead a study focused on separating existing quality systems from a current partner and reintegrating them back into operations., * Conduct a comprehensive assessment of current quality systems shared with the partner organization.

• Develop a detailed plan for system separation and reintegration into our infrastructure.
• Collaborate with cross-functional teams to ensure compliance with regulatory and corporate standards.
• Provide expert guidance on risk mitigation, data integrity, and system validation during the transition.
• Prepare documentation and reports outlining findings, recommendations, and timelines.

• Master's degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Biotechnology, or equivalent experience.
• Experience: 10-15 years in Quality Systems management and consulting.
• Proven track record of managing complex quality system projects in a regulated environment (pharmaceutical or medical device industry preferred).
• Strong knowledge of GxP, ISO standards, and regulatory compliance requirements.
• Ability to work independently and communicate effectively across global teams.
• Excellent communication skills in English & Dutch.

Capgemini ist einer der weltweit führenden Anbieter von Management- und IT-Beratung, Technologie-Services und Digitaler Transformation. Als ein Wegbereiter für Innovation unterstützt das Unternehmen seine Kunden bei deren komplexen Herausforderungen rund um Cloud, Digital und Plattformen.