At a Glance
- Tasks: Lead quality assurance for a pivotal gene therapy trial and shape GxP quality systems.
- Company: AI-driven biotech company with a strong gene therapy programme.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with potential to oversee AI-driven trial systems.
- Why this job: Make a real impact in cutting-edge gene therapy and influence quality standards.
- Qualifications: 10+ years in GxP quality assurance with strong GCP knowledge.
The predicted salary is between 66150 - 80850 £ per year.
We're partnering confidentially with a very well-funded, AI-driven biotechnology company with a gene therapy programme moving into a pivotal Phase III trial. Backed by leading academic and investment partners, this is a mature, well-resourced programme - not an early-stage concept.
They're looking for a hands-on QA/GxP Lead to be the day-to-day quality voice on the programme, owning and evolving a fit-for-purpose GxP quality system from an early stage. This is a genuine individual-contributor role with real scope to shape how quality is done, reporting to the Director of Quality.
What you'll own:
- Sponsor-side GCP quality system for a Phase III gene therapy trial (ICH E6(R3), 21 CFR Parts 11/50/56/312, EU CTR)
- Risk-based oversight of CROs, investigator sites, and vendors - quality agreements, audits, KQIs/KRIs
- The GMP-GCP interface for the investigational product, working closely with an external manufacturing partner
- Inspection readiness and hosting for FDA, EMA, and MHRA
- Growing oversight of AI-driven trial systems as they're integrated into the programme
What you'll bring:
- 10+ years' GxP quality assurance experience in clinical trials (sponsor, CRO, pharma, or biotech)
- Strong, current knowledge of GCP (ICH E6(R3)) and the GMP-GCP interface for investigational products
- A track record of overseeing external partners through quality agreements and risk-based oversight, rather than direct operational control
- Comfortable operating lean, and confident influencing partners you don't directly manage
Nice to have:
- Experience leading regulatory inspections
- Phase III/pivotal trial exposure
- Cell & gene therapy/ATMP background
- CSV/GAMP 5 or AI risk framework knowledge (EU AI Act, ISO/IEC 42001)
Location: London (Soho), 3 days/week in-office
QA/GxP Lead in London employer: Barrington James
As a Quality Control Scientist in our leading pharmaceutical/biotech QC laboratory, you will thrive in a collaborative team environment that prioritises scientific excellence and compliance with GMP standards. We offer competitive day rates and the opportunity to enhance your skills in microbiology and quality control testing, ensuring your professional growth in a fast-paced and regulated setting.
StudySmarter Expert Advice🤫
We think this is how you could land QA/GxP Lead in London
✨Get Involved in Local Research Communities
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We think you need these skills to ace QA/GxP Lead in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Barrington James that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Barrington James.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Barrington James does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Barrington James
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Barrington James. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Barrington James's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Barrington James. This shows your passion for the industry!
