Quality (QA) Lead – CDMO
Join Mytos as a Quality Assurance Lead to drive quality at the world’s first automated CDMO for regenerative medicine.
About Us
Mytos develops fully automated cell manufacturing sites powered by custom robotics to scale therapies to millions of patients. Backed by Y Combinator, we’ve partnered across Parkinson’s, hearing loss, bone repair, and raised $24m to accelerate global production.
Responsibilities
* Lead Mytos toward an MHRA MIA(IMP) license for our first site as fast as possible, without compromising on quality.
* Establish a robust and scalable Quality Production System (QPS) and maintain it.
* Ensure all production activities comply with 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 business goals.
* Lead and support audits.
* Prepare Mytos for future commercial batch release.
Qualifications
* 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 QPS systems covering document control, deviations, CAPA, change control, validation, and training.
* 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.
Nice to Have
* Experience in the release of ATMP products – ideally PSC‑derived Cell Therapies.
* Have previously set up a QPS from scratch and obtained an 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.
Salary & Benefits
* Competitive salary with stock options.
* Lunch covered daily.
* Collaborative team environment with very high potential to learn new skills.
* 24 days holiday (excluding bank holidays).
* Pension.
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.
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