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C&Q Manager

C&Q Manager

Blackfield AssociatesGhent, Flemish Region, Belgium
Il y a 25 jours
Description de poste

Job Title : Commissioning & Qualification (C&Q) Manager – CAR-T Therapy Expansion

Location : Ghent, Belgium

Contract Duration : 12 months (with possible extension)

Languages Required : Dutch & English

Project Overview :

We are currently seeking a skilled Commissioning & Qualification (C&Q) Manager to support a major €150 million CAR-T therapy expansion project in Ghent, Belgium , running in parallel with a compliance remediation initiative . This role will focus on ensuring all systems and equipment are properly qualified and ready for GMP operations, contributing directly to the site's operational readiness .

Key Responsibilities :

  • Lead all Commissioning & Qualification (C&Q) activities across multiple workstreams.
  • Define and implement C&Q strategies, plans, protocols (IQ / OQ / PQ), and timelines.
  • Manage qualification efforts for Upstream and Downstream process equipment .
  • Oversee qualification of supporting equipment such as :
  • Incubators , Isolators , Fridges / Freezers , and Temperature Mapping systems .
  • Support remediation efforts by identifying and closing qualification and compliance gaps.
  • Collaborate cross-functionally with Engineering, QA, Validation, Manufacturing, and Operations.
  • Contribute to achieving operational readiness , including handover to end users and GMP manufacturing.
  • Act as the C&Q interface between Belgian and Danish stakeholders.

Required Skills & Experience :

  • Solid experience in C&Q management within pharmaceutical or biopharma manufacturing environments.
  • Hands-on knowledge of Upstream and Downstream equipment in small-scale biotech or cell therapy.
  • Experience qualifying support equipment such as incubators, isolators, cold storage, and environmental mapping tools.
  • Strong Process Engineering background.
  • Prior exposure to remediation projects and understanding of GMP compliance requirements.
  • Fluency in Dutch and English is required.
  • Proactive leadership skills and ability to manage multi-disciplinary teams on complex projects.
  • Availability to work on-site in Ghent.
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    Manager • Ghent, Flemish Region, Belgium