Manager, Quality Engineering - Lab & CSV Systems

Johnson & Johnson Innovative Medicine; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Excellent benefits

Annual bonus

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Manager Quality Engineering – Lab and Computerized System Validation in Geel, Belgium. You will lead the QA Qualification/CSV team, ensuring quality governance for Lab, Automation, and IT systems used in API and DP Intermediates manufacturing within the IM site.

You will manage resources, budget, and KPIs, drive compliance, and prepare for inspections. The role offers an international, purpose-driven environment with development and strong benefits.

Qualifications

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Fluent in Dutch and English (written and spoken).
• Thorough knowledge of cGMP regulations and guidelines.
• Knowledge of GMP systems landscape: Lab systems and IT & Automation Systems.
• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
• Collaboration and teaming skills.
• Mindset for innovation and optimization.

Responsabilités

• Assuring that the qualification/CSV status is maintained during the life cycle of the systems in scope.
• Review and approval of qualification/CSV documents, Periodic System Quality Reviews, Validation Master Plans, Periodic Trend reports, calibration procedures and records.
• Participate in system introduction and system change projects and assure quality and compliance aspects.
• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification/CSV related matters during audits.
• Ensuring that deviations related to systems (qualification/CSV, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.
• Pro-actively and continuously challenge the quality of the qualification/CSV processes to improve the performance and develop improvements.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification/CSV.

Connaissances

Dutch & English

Analytical thinking

Risk assessment

Leadership skills

Collaboration

Formation

Master scientific degree or equivalent experience

Description du poste

Johnson & Johnson Innovative Medicine seeks a Manager Quality Engineering – Lab and Computerized System Validation in Geel, Belgium. You will lead the QA Qualification/CSV team, ensuring quality governance for Lab, Automation, and IT systems used in API and DP Intermediates manufacturing within the IM site.

You will manage resources, budget, and KPIs, drive compliance, and prepare for inspections. The role offers an international, purpose-driven environment with development and strong benefits.