Quality (QA) Lead - CDMO in Harrow
Quality (QA) Lead - CDMO

Quality (QA) Lead - CDMO in Harrow

Harrow Full-Time 48000 - 72000 £ / year (est.) No home office possible
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At a Glance

  • 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 collaborative environment.
  • Qualifications: 5+ years of QA experience in GxP environments, ideally with ATMPs or biologics.
  • Other info: Fast-paced setting with high potential for career growth and learning.

The predicted salary is between 48000 - 72000 £ 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 Harrow employer: Mytos

Mytos is an exceptional employer, offering a dynamic and collaborative work environment where innovation meets purpose in the field of regenerative medicine. With competitive salaries, stock options, and daily lunch coverage, employees are supported in their professional growth while contributing to groundbreaking advancements in healthcare. The company's commitment to quality and employee development ensures that team members can thrive and make a meaningful impact on global health.
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Contact Detail:

Mytos Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Quality (QA) Lead - CDMO in Harrow

✨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 can’t stress enough how personal connections can open doors that applications alone can’t.

✨Tip Number 2

Prepare for interviews by researching Mytos and understanding our mission in regenerative medicine. We want to see your passion for quality assurance and how you can contribute to our goals. Tailor your responses to show how your experience aligns with what we’re looking for.

✨Tip Number 3

Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We believe that being well-prepared can make all the difference when it comes to landing that Quality (QA) Lead role.

✨Tip Number 4

Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression. We appreciate candidates who show enthusiasm and professionalism, so let us know you’re keen on joining the Mytos team!

We think you need these skills to ace Quality (QA) Lead - CDMO in Harrow

Quality Assurance (QA)
GxP Compliance
MHRA and EU GMP Knowledge
Quality Production System (QPS) Development
Document Control
Deviations Management
CAPA (Corrective and Preventive Actions)
Change Control
Validation
Training
Auditing Experience
Excellent Written and Verbal Communication Skills
Experience with eQMS (MasterControl)
Knowledge of FDA Regulations
Ability to Work in a Fast-Paced Environment

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’s super easy, and you’ll be able to submit all your documents in one go. Plus, it helps us keep everything organised!

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 instances where you successfully led audits or established quality systems, as this will demonstrate your hands-on experience.

✨Communicate Clearly

Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to refine your delivery and ensure you come across as confident and knowledgeable.

✨Align with Company Goals

Research Mytos and understand their mission and goals. Be ready to discuss how your quality strategy can align with their business objectives, particularly in scaling therapies and preparing for commercial batch releases. This shows that you're not just looking for a job, but that you're genuinely interested in contributing to their success.

Quality (QA) Lead - CDMO in Harrow
Mytos
Location: Harrow

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