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For Companies At a Glance
- Tasks: Oversee GMP for innovative gene-modified cell therapy manufacturing and testing.
- Company: Join Quell, a pioneering biopharmaceutical company transforming patient therapies.
- Benefits: Enjoy 25 days holiday, private medical insurance, and a generous pension scheme.
- Other info: Collaborative environment with opportunities for growth and innovation.
- Why this job: Make a real impact in the biopharmaceutical field with cutting-edge technology.
- Qualifications: Experience in pharmaceutical quality assurance and a degree in biological science or chemistry.
The predicted salary is between 50000 - 65000 ÂŁ per year.
ABOUT US
At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
OUR COMPANY
Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The company was founded with initial Series A financing, led by Syncona Ltd who committed $83M with a further $1M contributed by UCL Technology Fund.
THE ROLE
The Senior QA Specialist (12-month FTC maternity cover) is responsible for the GMP oversight of clinical phase, gene-modified cell therapy product manufacturing and testing. This includes the execution and reporting of GSTT GMP PQS systems, the design, improvement, execution and reporting of Quell PQS systems, and oversight of outsourced GMP activities. This is an office-based role at Quell’s London Bridge office.
MAIN RESPONSIBILITIES
- Day‑to‑day responsibilities for execution and reporting of outsourced GMP PQS systems controlling the manufacturing and testing of clinical phase, gene‑modified cell therapy products, in accordance with GMP including:
- Batch review and QP certification process
- Product specification file maintenance
- Deviations
- Change controls
- CAPA
- Quality risk management
- Quality metric reporting
- Self‑inspections
- Vendor qualification and monitoring
- Training
- EU QP batch review and certification
EXPERIENCE, TECHNICAL & EDUCATIONAL REQUIREMENTS
Technical Requirements
- Previous experience pharmaceutical quality assurance supporting the development and GMP manufacture of ATMPs (or equivalent products e.g. aseptically compounded Special's, biologics, innovative medicines) and an applied knowledge of the GMP requirements of aseptic manufacturing.
- Working knowledge of regulatory requirements (UK and EU GMP, ICH) for clinical stage sterile products, including ATMPs.
- High attention to detail, strong organisational and communication skills, and ability to manage confidential and trade secret information appropriately.
- Ideally, experience of Lean processes supporting late‑stage clinical trial or commercial ATMP or biologics processes.
- Experience in providing scientifically sound, risk‑based and phase‑appropriate quality guidance to cross‑functional teams.
- Proven record of implementing, monitoring, and continuously improving quality systems and ensuring data integrity and compliance.
- Excellent written communication style, able to produce clear, succinct high‑quality GMP documents.
- Experience implementing, or working within, an eQMS.
- Demonstrated application of risk management tools.
Educational Requirements
- University degree in a biological science, chemistry or equivalent.
BENEFITS
- Holidays: 25 days per year
- Life Assurance: 4 x base salary
- Group Personal Pension: Auto‑enrolled at 6% employer contribution, 3% employee contribution
- Private Medical Insurance for your whole family
- Health Cash Plan
- Annual Bonus
PERKS
- Fantastic collaborative environment at Translation & Innovation Hub
- £61 million investment including brand new lab equipment, innovative methods, and exposure to cutting‑edge technology
- Flexible working
- Fast‑paced and progressive company looking for future leaders and innovators
Senior GMP QA Specialist (12-month FTC Maternity Cover) in London employer: Quell Therapeutics
Contact Detail:
Quell Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior GMP QA Specialist (12-month FTC Maternity Cover) in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those connected to Quell. A friendly chat can sometimes lead to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching Quell’s recent projects and innovations. Show us you’re genuinely interested in our mission and how your skills can contribute to our goals.
✨Tip Number 3
Practice common interview questions related to GMP and quality assurance. We want to see how you handle real-world scenarios, so think of examples from your past experiences.
✨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 us you’re keen on joining our team.
We think you need these skills to ace Senior GMP QA Specialist (12-month FTC Maternity Cover) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior GMP QA Specialist role. Highlight your relevant experience in pharmaceutical quality assurance and any specific projects related to ATMPs. We want to see how your background aligns with our mission at Quell!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your skills can contribute to our innovative therapies. Keep it concise but impactful – we love a good story!
Showcase Your Attention to Detail: Given the nature of the role, it's crucial to demonstrate your attention to detail. Make sure there are no typos or formatting issues in your application. A polished application reflects your commitment to quality, which is key for us at Quell.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Quell Therapeutics
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge, especially as it relates to gene-modified cell therapy products. Be prepared to discuss specific examples from your past experience where you've ensured compliance with GMP standards.
✨Showcase Your Attention to Detail
In this role, attention to detail is crucial. Bring examples of how you've managed batch reviews, deviations, and change controls in previous positions. Highlight any experiences where your meticulous nature led to successful outcomes.
✨Demonstrate Cross-Functional Collaboration
Quell values teamwork across various functions. Prepare to share instances where you've worked with different teams, such as R&D or clinical operations, to improve quality systems or resolve issues. This will show your ability to be a quality subject matter expert.
✨Prepare for Risk Management Questions
Expect questions about risk-based assessments and how you've handled deviations or changes in the past. Think of specific scenarios where your risk management skills made a difference, and be ready to explain your thought process.