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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 healthcare while developing your skills in a fast-paced environment.
- Qualifications: 5+ years of QA experience in GxP environments, ideally with ATMPs or biologics.
- Other info: Collaborative team culture with high potential for learning and growth.
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.
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.
Quality (QA) Lead - CDMO in Harrow on the Hill employer: Mytos
Contact Detail:
Mytos Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality (QA) Lead - CDMO in Harrow on the Hill
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Mytos and understanding their mission. Tailor your answers to show how your experience aligns with their goals, especially around quality assurance and compliance.
✨Tip Number 3
Practice common interview questions related to QA and GxP environments. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining the Mytos team.
We think you need these skills to ace Quality (QA) Lead - CDMO in Harrow on the Hill
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality (QA) Lead role. Highlight your relevant experience in GxP environments and any specific achievements related to MHRA and EU GMP compliance. We want to see how your background aligns with our mission at Mytos!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in regenerative medicine and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Skills: Don’t forget to showcase your skills in QPS systems, auditing, and communication. We’re looking for someone who can elevate our quality culture, so make sure to mention any relevant experiences that demonstrate your expertise.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
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.
