Quality (QA) Lead - CDMO

9 мес. назад

United KingdomEuropeLeadOnsite

Lead Quality Assurance to ensure quality standards in a cell manufacturing and regenerative medicine company.

About Us You rarely get the chance to change an entire industry. But that's the position we find ourselves in. Join us, and you’ll help scale cures to patients that need them sooner.   We’ve developed fully-automated cell manufacturing sites powered by custom robotics - to scale therapies to millions of patients. Last year, patients were cured of diseases like Parkinson’s and vision loss using stem-cell derived cells - but today these Regenerative Medicines are produced by hand, meaning they’re too expensive and hard to scale. With our automated CDMO, these therapies can now be scaled globally at low cost.    We've announced partnerships across multiple therapies so far ranging from Parkinson’s , to hearing loss, to bone repair - and raised $24m to expand into the market fas

Lead an MHRA MIA(IMP) license for our the first site as fast as possible, without compromising on quality
Take the lead in establishing a robust and scalable PQS, and maintaining it
Ensure all aspects of our production are managed in compliance with our quality policies and procedures
Elevate the team’s quality understanding, and reinforce an efficient quality culture
Work with leadership to plan quality strategy to hit our business goals
Lead and support audits
Prepare for future commercial batch release

Significant QA experience (>5 years) in a GxP environment, ideally in ATMPs, biologics, or cell therapy
Strong understanding of MHRA and EU GMP, with hands-on experience preparing for inspections
Experience with PQS systems covering document control, deviations, CAPA, change control, validation, and training
You meet MHRA requirements to be a Quality Controller on the MIA(IMP) license
Experience in auditing and being audited
Comfortable working in a fast paced environment
Excellent written and verbal communication skills

Experience in the release of ATMP products - ideally PSC-derived Cell Therapies
Have previously setup a PQS from scratch, and obtained a MIA(IMP) license
Experience setting up electronic systems such as eQMS (MasterControl) and electronic Batch Records/Manufacturing execution systems
Knowledge and experience with FDA regulations