At a Glance
- Tasks: Lead quality assurance for cutting-edge gene therapy projects and ensure compliance across operations.
- Company: Innovative biotech firm at the forefront of gene therapy and AI technologies.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Collaborate with diverse teams in a mission-driven setting in London.
- Why this job: Make a real impact in life-changing therapies while shaping quality processes.
- Qualifications: 10+ years in GxP Quality Assurance with strong knowledge of GCP and GMP.
The predicted salary is between 60000 - 75000 £ per year.
- Quality Assurance Lead (Gx P) - Cell & Gene Therapy
- We are seeking an experienced
Quality Assurance Lead to provide quality leadership for a late-stage gene therapy programme.
This is a hands-on individual contributor role with responsibility across GCP, GMP oversight, vendor management, inspection readiness, and quality systems.
You will act as the key quality representative within a pivotal Phase III clinical programme, ensuring compliance across clinical operations, external partners, and manufacturing activities while helping build and enhance a fit-for-purpose Gx P quality framework.
- GCP Quality & Clinical Oversight
- Lead sponsor-side GCP quality activities for a Phase III gene therapy programme.
- Manage vendor, CRO, laboratory, and site oversight through risk-based quality management.
- Oversee deviations, CAPAs, audits, inspections, and quality agreements.
- Drive inspection readiness and promote a strong quality culture.
- GMP & Manufacturing Oversight
- Act as QA partner to external manufacturing organisations.
- Support GMP compliance, change control, batch disposition, and quality agreements.
- Manage the GMP-GCP interface for investigational products.
- Support quality activities relating to ATMPs, biosafety, and traceability requirements.
- AI & Computerised Systems
- Support oversight of AI-enabled clinical technologies.
- Ensure compliance with CSV, GAMP 5, data integrity, and Part 11 requirements.
- Contribute to AI governance, validation, and risk management activities.
- Monitor quality metrics and supplier performance.
- Drive quality system improvements and training initiatives.
- Support regulatory submissions and health authority interactions.
- What You'll Bring
- Degree in Life Sciences, Pharmacy, Quality, Engineering, or related field.
- 10+ years' experience in Gx P Quality Assurance within pharma, biotech, sponsor, or CRO environments.
- Strong knowledge of GCP and the GMP-GCP interface.
- Experience managing external vendors and quality agreements.
- Proven background in deviations, CAPAs, audits, inspections, and quality risk management.
- Ability to influence stakeholders in a fast-paced, growing organisation.
- Phase III or pivotal trial experience.
- Cell & Gene Therapy / ATMP experience.
- GMP or CMC quality oversight experience.
- CSV, GAMP 5, data integrity, and Part 11 knowledge.
- Experience with regulatory inspections and submissions.
- Knowledge of AI governance frameworks and regulatory expectations.
Why Join?
- Play a critical role in a late-stage gene therapy programme.
- Work at the intersection of biotechnology, AI, and clinical development.
- Own and shape quality processes in a growing, innovative organisation.
- Gain exposure to advanced therapies and emerging AI-enabled clinical technologies.
- Location
London-based role with close collaboration across clinical, quality, regulatory, and technology teams in a highly innovative and mission-driven environment.
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Quality Assurance Lead in London employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the vibrant streaming and entertainment sector. Employees benefit from immediate project impact opportunities, comprehensive training, and career growth in a cloud-oriented environment, making it an ideal place for those looking to advance their skills in data engineering while working with cutting-edge technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Lead in London
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We think you need these skills to ace Quality Assurance Lead in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Cpl Life Sciences!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Cpl Life Sciences that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Cpl Life Sciences!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Cpl Life Sciences, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Cpl Life Sciences
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Cpl Life Sciences that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Cpl Life Sciences’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
