Quality Assurance Lead (Est/Gene Therapy)

(CAR-T/Cell Therapy a MUST

(Occasional travel to Europe)

Scope of the project

We are looking for a QA Lead consultant located on the North East coast of the US to join us in setting up, promoting and maintaining the QA model for our sites.

Responsibilities:

• Compliance development to enhance consistency
• Manufacturing site qualification and onboarding
• Setting up the quality management system for point-of-care manufacturing monitoring in alignment with EU and US regulatory guidelines, working together with the EU team.
• Maintain product quality oversight, creating consistency using CellPoint’s central site capabilities and data.
• Manufacturing quality auditing and monitoring
• Performance oversight for point-of-care manufacturing partners by development of PoC quality oversight system applying the digital tools available, including

The QA consultant reports to the QA Director based in the central EU site.

Job requirements

Who are you?

• You have good interpersonal skills
• Experience in a commercial GMP manufacturing setting is preferred
• You are able to travel for on-site visits to PoC sites for F2F interaction with stakeholders
• You are proficient in project management
• Experience in a ATMP manufacturing setting is preferred
• With at least 5 years of experience in a senior role within a GMP environment with thorough working knowledge of cGMP QA processes.
• Result-driven and can-do mindset, without compromising quality and compliance
• You have a relevant master’s degree
• You are an independent thinker and resourceful
• You enjoy working in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities