At a Glance
- Tasks: Shape and deliver quality frameworks in a pioneering biotech environment.
- Company: Innovative UK-based biotech with strong funding and a novel therapeutic pipeline.
- Benefits: Flexible contract, competitive rate, and high autonomy.
- Other info: Fast-paced environment with opportunities for professional growth.
- Why this job: Join at a critical stage and make a real impact on clinical development.
- Qualifications: Proven GCP QA experience in biotech or pharma and strong audit skills.
The predicted salary is between 50000 - 65000 £ per year.
Your new company
You will be supporting an innovative UK-based biotech entering first-in-human studies, backed by strong funding and progressing a novel therapeutic pipeline into early clinical development. The organisation is at a pivotal stage, building out its clinical and quality infrastructure as it transitions toward the clinic.
Your new role
As a GxP QA Consultant (GCP led), you will play a key role in shaping and delivering the organisation's quality framework, with a primary focus on GCP but with exposure across broader GxP disciplines (GLP / GMP depending on pipeline and scope).
Key responsibilities will include:
- Supporting the development and streamlining of GCP SOPs
- Providing QA oversight of CROs and clinical vendors
- Conducting and supporting GCP audits (internal/vendor/study-level)
- Driving inspection readiness (MHRA/FDA/EMA)
- Advising on phase appropriate QMS build without overengineering
This is a high-impact role, working closely with senior leadership in a growing biotech environment.
What you'll need to succeed
- Proven experience within GCP QA in biotech or pharma environments
- Strong background supporting early clinical / FIH studies
- Experience building or improving QMS frameworks and SOPs
- Hands-on experience with audits and vendor oversight
- Ability to work autonomously in a fast-paced, evolving environment
What you'll get in return
- Opportunity to support a biotech at a critical inflection point
- Exposure to end-to-end QMS build and FIH readiness
- Flexible, high-autonomy contract environment
- Competitive Rate
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
GCP QA Consultant (Contract) in Cheltenham employer: Hays
Join a pioneering UK-based biotech at the forefront of innovative therapeutic development, where you will have the opportunity to shape the quality framework in a dynamic and supportive environment. With a strong focus on employee growth, you will benefit from flexible working arrangements and the chance to work closely with senior leadership, making a meaningful impact as the company transitions into clinical stages. This role offers a unique blend of autonomy and collaboration, ensuring that your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land GCP QA Consultant (Contract) in Cheltenham
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars to meet potential employers and get your name out there. Remember, it’s all about who you know!
✨Tip Number 2
Prepare for interviews by researching the company thoroughly. Understand their pipeline and recent developments. This will help you tailor your answers and show that you're genuinely interested in their work.
✨Tip Number 3
Showcase your hands-on experience! Be ready to discuss specific examples of how you've improved QMS frameworks or conducted audits. Real-life stories can make you stand out from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace GCP QA Consultant (Contract) in Cheltenham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your GCP QA experience and any relevant biotech or pharma roles. We want to see how your background aligns with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this role. Share specific examples of your experience with GCP SOPs and audits, and how you've contributed to QMS frameworks in the past.
Showcase Your Autonomy:Since this role requires working autonomously, give us examples of how you've thrived in fast-paced environments. We love to see candidates who can take initiative and drive projects forward.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Hays
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice (GCP) knowledge. Be ready to discuss specific examples from your past experiences where you've implemented GCP guidelines, especially in early clinical studies. This will show that you’re not just familiar with the theory but have practical insights to offer.
✨Showcase Your Audit Experience
Prepare to talk about your hands-on experience with audits and vendor oversight. Think of a couple of key audits you've conducted or been involved in, and be ready to explain the challenges you faced and how you overcame them. This will demonstrate your problem-solving skills and attention to detail.
✨Understand the Company’s Pipeline
Do your homework on the biotech's therapeutic pipeline and their current projects. Being able to discuss how your role as a GCP QA Consultant can directly impact their first-in-human studies will show your genuine interest in the company and its mission.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your ability to work autonomously in a fast-paced environment. Think about situations where you had to make quick decisions or adapt to changes in project scope, and be prepared to share those stories. This will highlight your adaptability and critical thinking skills.
