Quality Person

Oxida - 147999
Regio Gent

Wat doe je als Quality Person

  • Serves as a Quality person in plant in support of cell therapy manufacturing.
  • Ensures Quality Oversight in plant covering various process related activities
  • Performs periodic Quality checks/audits related to process, documentation and process manipulations
  • Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance.
  • Responsible for real time review of process documentation in support of process unit operations and release activities where needed.
  • Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
  • Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
  • Review and approve manufacturing procedures and batch records
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Support regulatory inspections and audits by ensuring inspection readiness within facility.
  • Perform internal housekeeping audits.
  • Other duties will be assigned, as necessary.

Gewenste profiel

  • Aseptic processing in ISO 5 clean room and biosafety cabinets.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  • Great attention to detail and ability to follow the procedures.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  • Good written and verbal communication skills are required.
  • Ability to summarize and present results, and experience with team-based collaborations is a must.
  • Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  • Must exhibit strong leadership skills and effectively develop others.
  • Ability to collaborate well with stakeholders, customers and peers.
  • Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  • Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
  • Ability to manage conflict and issues that arise with internal or external customers.


  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • Matched 401K
  • Flexible Spending Account
  • Health Savings Account
  • AD&D Insurance
  • Short-Term Disability
  • Long-Term Disability
  • Paid Maternity Leave
  • Paid Paternity Leave
  • Pet Insurance
  • Critical Illness Insurance
  • Hospital Indemnity Insurance
  • Accident Insurance
  • Legal Insurance
  • Commuter Benefits
  • Employee Assistance Program
Ine Verstraete Office Manager

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