C&Q Manager

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.