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GMP Quality Manager

Job description
  • In close collaboration with the manufacturing teams:

              o review of deviation investigations and related corrective and preventive actions of review of change controls
              o review batch record documentation and support release of IMP for clinical studies
              o review of annual product reviews

  • Review quality agreements with external parties.
  • Support the Global External Audit Program through the execution of qualification audits and routine GMP audits; Support HA inspection, mock   inspections and pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections.
  • Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation.
  • Support internal audit program.
  • Support the further build-out of quality processes and systems enabling successful launch of a commercial product.
Skills and personality
  • 5y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations.
  • Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA, ...) is a plus.
  • In-depth knowledge of FDA and EU regulations and ICH Guidelines.
  • Strong technical mastery, analytical and investigation skills.
  • Able to work effectively together with both internal and external stakeholders.
  • Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines.
  •  Fluent in English – our working language.
Contract

Executive search

Experience

minimum 5 years

Education

Higher Education

Languages

English

Sector

Pharmaceutical industry

Region

Gent

Job type

Full-time

 
 

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