genesis quality partner.

As a Genesis Quality Partner, you will :

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

Here are the requirements as a Genesis Quality Partner:

• Scientific master’s degree or equivalent
• At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
• Experience of a new manufacturing facility 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
• Very good written and spoken English and French
• QP Registration in Belgium is an asset

Competencies:

• Be able to make Quality decisions, even with business pressure; adapt the level of requirements to the needs
• Interpersonal skills to communicate and maintain good working relationship with internal and external customers
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk-based approach
• Able to understand customers’ needs and technical requirements
• Prioritization and time management skills
• Problem solving and drive for results