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- Tasks: Lead quality assurance for innovative automated cell manufacturing in regenerative medicine.
- Company: Join Mytos, a pioneering company backed by Y Combinator.
- Benefits: Competitive salary, stock options, daily lunch, and 24 days holiday.
- Why this job: Make a real impact in cutting-edge therapies and elevate quality standards.
- Qualifications: 5+ years QA experience in GxP environments, ideally with ATMPs or biologics.
- Other info: Collaborative team culture with high potential for skill development.
The predicted salary is between 36000 - 60000 £ per year.
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.
Quality (QA) Lead - CDMO in London employer: Mytos
Contact Detail:
Mytos Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality (QA) Lead - CDMO in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality Assurance Lead role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MHRA and EU GMP regulations. We recommend practising common interview questions related to quality systems and compliance. Show them you’re the expert they need to drive quality at Mytos!
✨Tip Number 3
Don’t forget to showcase your hands-on experience with QPS systems during interviews. We want to hear about your successes and how you’ve elevated quality culture in previous roles. Be ready to share specific examples that highlight your skills!
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly. Let’s get you on board to help shape the future of regenerative medicine!
We think you need these skills to ace Quality (QA) Lead - CDMO in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality (QA) Lead role. Highlight your significant QA experience and any specific projects related to GxP environments, especially in ATMPs or cell therapy. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to Mytos. Mention your understanding of MHRA and EU GMP, and any relevant experiences that showcase your skills.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! If you've set up a QPS from scratch or led successful audits, let us know. Numbers and specific outcomes can really make your application stand out.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It helps us keep everything organised and ensures your application reaches the right people. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Mytos
✨Know Your Quality Standards
Make sure you brush up on your knowledge of MHRA and EU GMP regulations. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you can apply them in a practical setting.
✨Showcase Your Experience
Prepare specific examples from your past QA roles, especially those involving GxP environments or ATMPs. Highlight any experience you have with QPS systems and how you've successfully navigated audits or inspections.
✨Demonstrate Leadership Skills
As a QA Lead, you’ll need to elevate the team’s quality understanding. Be ready to discuss how you’ve previously fostered a quality culture within a team and how you plan to do the same at Mytos.
✨Ask Insightful Questions
Prepare thoughtful questions about Mytos’ current quality strategies and future goals. This shows your genuine interest in the role and helps you understand how you can contribute to their mission in regenerative medicine.
