Gene Therapy Operations Manager

il y a 6 jours


Brainel'Alleud, Wallonie, Belgique TN Belgium Temps plein

About the Role:

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This Gene Therapy Operations Manager will support the Genesis project GMP Readiness program to timely obtain health authorities' authorization to manufacture Gene Therapy clinical batches in a new facility pilot plant.

Key Responsibilities:

  • Drive the implementation of new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
  • Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
  • Manage materials and product specifications, execute incoming materials release.
  • Contribute to the consolidation and writing of the Contamination Control Strategy.
  • Drive supplier qualification programs.
  • Establish and drive inspection readiness programs.
  • Prepare the new Gene Therapy Facility Site Master File.

Requirements:

  • Scientific master's degree or equivalent.
  • At least 5-8 years of QA oversight experience in a GMP manufacturing environment.
  • Experience with new manufacturing facilities seeking Health Authorities certification.
  • Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing.
  • Experience in health authorities' inspections.
  • Strong knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing.
  • Fluency in English and French.
  • QP Registration in Belgium is an asset.
  • Demonstrated ability to collaborate with senior stakeholders.
  • Strong understanding of risk-based approaches.
  • Able to understand customers' needs and technical requirements.

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