Quality (QA) Lead - CDMO

About UsYou 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 faster, and accelerate our development! Within the next 12-18 months, neurons grown on our machines will be going into Parkinson’s patient brains.We’ve assembled a world-class team to take on this challenge, with ex-Dyson engineers and Nature-published scientists working hand-in-hand. You can learn more about your potential Mytos teammates here: TeamMytos is backed by Y Combinator, the most successful startup program in the world which produced companies such as AirBnb, Dropbox, and Ginkgo Bioworks.The RoleWe’re looking for an ambitious and pragmatic Quality Assurance Lead to work with leadership to ensure quality moves in hand in hand with business vision. You’ll work on moving us fast towards our MHRA Manufacturing and Import Authorisation (MIA) license for our first site. You’ll get to collaborate with our advisors, such as former VP Quality for Cell and Gene Therapy at Catalent, and the former CTO of Regenerative Medicine at Resilience. This is a unique opportunity to establish quality at the world’s first automated CDMO for Regenerative Medicine.What you'll be doing:Lead Mytos an MHRA MIA(IMP) license for our the first site as fast as possible, without compromising on qualityTake the lead in establishing a robust and scalable PQS, and maintaining itEnsure all aspects of our production are managed in compliance with our quality policies and proceduresElevate the team’s quality understanding, and reinforce an efficient quality cultureWork with leadership to plan quality strategy to hit our business goalsLead and support auditsPrepare Mytos for future commercial batch releaseYou bring:Significant QA experience (>5 years) in a GxP environment, ideally in ATMPs, biologics, or cell therapyStrong understanding of MHRA and EU GMP, with hands-on experience preparing for inspectionsExperience with PQS systems covering document control, deviations, CAPA, change control, validation, and trainingYou meet MHRA requirements to be a Quality Controller on the MIA(IMP) licenseExperience in auditing and being auditedComfortable working in a fast paced environmentExcellent written and verbal communication skillsNice to have:Experience in the release of ATMP products - ideally PSC-derived Cell TherapiesHave previously setup a PQS from scratch, and obtained a MIA(IMP) licenseExperience setting up electronic systems such as eQMS (MasterControl) and electronic Batch Records/Manufacturing execution systemsKnowledge and experience with FDA regulationsSalary and Benefits:Competitive salary with stock optionsLunch covered dailyCollaborative team environment with very high potential to learn new skills24 days holiday (excluding bank holidays)PensionWe’re building a team that enjoys moving fast, strives for continuous improvement through learning from mistakes and is passionate about work that contributes to solving real world problems.Join us if you want a fast-paced environment, where you’re empowered to make decisions and do the best work of your career.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.