Senior QA & Compliance Leader – GMP & QMS

Lonza Group Ltd.

Geleen

On-site

EUR 47,000 - 65,000

Full time

3 days ago
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Benefits offered by this job

Agile culture
Inclusive workplace
Compensation programs
Cross-functional collaboration
Global benefits

Job summary

Lonza Group Ltd. in Geleen, Netherlands is seeking a Senior QA Compliance Specialist to maintain and strengthen the QMS at the Geleen site.

You will apply expertise in QMS and quality event processes to help ensure GMP compliance, support inspection readiness, and drive continuous improvement. You will lead the Deviation Review Board, review quality events and CAPAs, author and maintain QMS documentation, support audits and inspections, deliver training on QMS topics, and collaborate with

Qualifications

  • At least 5 years of experience in quality management, quality systems, or compliance within a GMP-regulated environment.
  • Experience managing quality events, including deviations, CAPAs, change requests, investigations, and risk management activities.
  • Solid knowledge of QMS principles, GMP requirements, risk management, and inspection readiness.
  • Experience supporting audits, regulatory inspections, and broader compliance programs; sterile manufacturing is an advantage.
  • Strong analytical, problem-solving, decision-making, and stakeholder management skills across functions.
  • Experience developing or delivering training on quality and compliance topics.
  • Bachelor's degree or equivalent qualification in a life sciences field.

Responsibilities

  • Provide oversight of the site's Quality Management System, including quality events and risk management activities.
  • Lead the Deviation Review Board and review/approve systemic quality events, deviations, CAPAs, investigations, and audits.
  • Author, review, and maintain QMS documentation and support implementation of site/global standards.
  • Review and approve quality risk assessments and support risk management activities.
  • Support internal/external audits, regulatory inspections, and ongoing inspection readiness.
  • Deliver training on QMS and compliance topics to strengthen GMP knowledge across the site.

Skills

Quality management
Deviation handling
Risk management
Audit readiness
Training delivery
Stakeholder management

Education

Bachelor's degree

Tools

QMS software

Job description

Lonza Group Ltd. in Geleen, Netherlands is seeking a Senior QA Compliance Specialist to maintain and strengthen the QMS at the Geleen site.

You will apply expertise in QMS and quality event processes to help ensure GMP compliance, support inspection readiness, and drive continuous improvement. You will lead the Deviation Review Board, review quality events and CAPAs, author and maintain QMS documentation, support audits and inspections, deliver training on QMS topics, and collaborate with

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