GMP Manufacturing Compliance Coordinator

Lonza

Netherlands

On-site

Confidential

Full time

6 days ago
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Benefits offered by this job

Agile culture
Inclusive workplace
Performance-based compensation
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Job summary

Lonza Geleen is seeking a Manufacturing Compliance Coordinator to support GMP readiness and high-quality manufacturing of advanced therapies. You will collaborate with Manufacturing, QA and other functions to investigate quality events and drive continuous improvement.

This site-based role emphasizes close collaboration, rigorous documentation, and timely issue resolution to ensure compliance and product safety throughout the manufacturing lifecycle.

Qualifications

  • Bachelor's degree in Biotechnology, Life Sciences or related field.
  • Up to four years of experience in manufacturing/pharma/biotech.
  • Solid knowledge of cGMP in regulated environments.

Responsibilities

  • Support the Manufacturing Compliance Lead in maintaining readiness for routine GMP inspections and pre-approval inspections.
  • Initiate, review and revise batch records, SOPs, protocols, work instructions and other GMP-related documentation.
  • Investigate and manage quality events, including deviations, change controls and CAPAs, coordinating implementation, follow-up and timely closure in accordance with GMP requirements.
  • Work closely with Manufacturing Team Leads, Production Operators, Biotech Associates, Quality Assurance and other stakeholders to resolve quality issues and maintain compliance.
  • Identify potential risks to manufacturing delivery, elevate issues appropriately and independently seek practical solutions within established procedures.
  • Support internal and external audits and contribute to consistent GMP compliance across the Manufacturing organisation.
  • Drive continuous improvement in processes, planning and training, while providing cover for the Manufacturing Compliance Lead when required.

Skills

GMP knowledge
Planning & prioritisation
Problem solving
English communication

Education

Bachelor's degree in Biotechnology/Life Sciences

Job description

Lonza Geleen is seeking a Manufacturing Compliance Coordinator to support GMP readiness and high-quality manufacturing of advanced therapies. You will collaborate with Manufacturing, QA and other functions to investigate quality events and drive continuous improvement.

This site-based role emphasizes close collaboration, rigorous documentation, and timely issue resolution to ensure compliance and product safety throughout the manufacturing lifecycle.

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