At a Glance
- Tasks: Lead quality activities for clinical programmes and ensure compliance across GCP and GMP operations.
- Company: Innovative biotech company focused on late-stage clinical development.
- Benefits: Competitive salary, hybrid work model, and opportunities for career growth.
- Other info: Collaborative culture with significant autonomy and exposure to innovative projects.
- Why this job: Shape quality processes and make a real impact in a dynamic biotech environment.
- Qualifications: Degree in Life Sciences or related field with extensive GxP Quality Assurance experience.
The predicted salary is between 90000 - 90000 £ per year.
Job Title
QA/Gx P Lead
Job Type
Full-time, permanent
Location
London, UK - Hybrid
Remuneration
Cpl Life Sciences is partnering with an innovative biotech company to appoint a QA/Gx P Lead to support a late-stage clinical development programme.
This is an excellent opportunity for an experienced quality professional to take ownership of sponsor-side quality activities, ensuring compliance across GCP and GMP operations while supporting a complex and highly regulated clinical programme.
The role offers significant visibility, autonomy, and the opportunity to shape quality systems within a growing organisation.
Key Responsibilities
- Clinical Quality & GCP Oversight
- Lead sponsor-side GCP quality activities for a late-stage clinical programme.
- Implement risk-based oversight of CROs, investigator sites, laboratories, and external vendors.
- Manage quality events, deviations, CAPAs, and inspection readiness activities.
- Support quality governance and vendor oversight processes.
- Vendor & Manufacturing Quality
- Provide quality oversight of external manufacturing partners.
- Support quality agreements, change controls, investigations, and supplier management activities.
- Ensure compliant management of investigational products throughout the clinical supply chain.
- Computerised Systems & Data Integrity
- Support validation and oversight of Gx P-relevant computerised systems.
- Ensure compliance with data integrity requirements and electronic records regulations.
- Contribute to quality risk assessments relating to digital platforms and emerging technologies.
- Inspection Readiness & Regulatory Support
- Lead audit and inspection preparation activities.
- Support responses to regulatory inspections and partner audits.
- Contribute to quality aspects of regulatory submissions and health authority interactions.
Requirements
- Degree in Life Sciences, Pharmacy, Quality Assurance, Engineering, or related discipline.
- Extensive experience within Gx P Quality Assurance in a biotech, pharmaceutical, CRO, or clinical research environment.
- Strong knowledge of GCP regulations and clinical quality systems.
- Experience overseeing external vendors and service providers.
- Ability to influence stakeholders across a matrix organisation.
Desirable
- Experience supporting Phase III or pivotal clinical studies.
- Audit and regulatory inspection experience.
- GMP and CMC quality exposure.
- Knowledge of CSV, GAMP 5, data integrity, and electronic systems compliance.
- Experience within biologics, advanced therapies, cell therapy, or gene therapy.
- What's on Offer
- Opportunity to shape and enhance quality processes within a growing biotech organisation.
- Significant ownership and autonomy.
- Exposure to innovative clinical development programmes.
- Collaborative, high-performing environment.
- Strong potential for future career growth.
- For a confidential discussion or to learn more, please apply or contact me at
QA/GxP 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 QA/GxP Lead in London
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Cpl Life Sciences. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Cpl Life Sciences!
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 Cpl Life Sciences 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 Cpl Life Sciences.
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 Cpl Life Sciences 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 Cpl Life Sciences
✨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 Cpl Life Sciences. 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 Cpl Life Sciences'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 Cpl Life Sciences. This shows your passion for the industry!
