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: Competitive pay, flexible working, and the chance to make a real impact.
- Other info: High-impact role with opportunities for growth and collaboration with senior leadership.
- Why this job: Join a pivotal stage in biotech and influence early clinical development.
- Qualifications: Experience in GCP QA and supporting early clinical studies is essential.
The predicted salary is between 50000 - 70000 £ 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
GCP QA Consultant (Contract) employer: Hays
Join a pioneering UK-based biotech firm at the forefront of innovative therapeutic development, where your expertise as a GCP QA Consultant will directly influence the quality framework and clinical success. With a strong emphasis on employee growth, collaborative work culture, and the opportunity to shape critical processes in a dynamic environment, this role offers a unique chance to contribute to meaningful advancements in healthcare while working alongside experienced leaders in the field.
StudySmarter Expert Advice🤫
We think this is how you could land GCP QA Consultant (Contract)
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars where you can meet potential employers and showcase your expertise in GCP QA.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and related regulations. Be ready to discuss your experience with audits and QMS frameworks, as these are hot topics for the role you're aiming for.
✨Tip Number 3
Showcase your hands-on experience! Bring examples of how you've improved SOPs or conducted successful audits. This will help you stand out as someone who can make an immediate impact in the organisation.
✨Tip Number 4
Don't forget to apply through our website! We want to see your application and help you land that GCP QA Consultant role. Plus, it’s a great way to ensure your CV gets into the right hands.
We think you need these skills to ace GCP QA Consultant (Contract)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GCP QA Consultant role. Highlight your experience in biotech or pharma, especially with early clinical studies. We want to see how your background aligns with the key responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how you can contribute to shaping the quality framework. We love seeing genuine enthusiasm for the biotech field, so let that passion come through!
Showcase Relevant Skills:When filling out your application, make sure to showcase your skills in GCP SOP development, QA oversight, and audit experience. We’re looking for candidates who can demonstrate their hands-on experience and ability to drive inspection readiness.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company and culture while you’re at it!
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 not only understand the theory but can apply it practically.
✨Familiarise Yourself with the Company
Research the biotech company thoroughly. Understand their therapeutic pipeline and any recent news or developments. This will help you tailor your answers and demonstrate genuine interest in their work, which is crucial for a role that involves shaping their quality framework.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like conducting audits or ensuring inspection readiness. Think of real-life scenarios where you’ve successfully navigated challenges in QA, and be ready to share these stories to highlight your problem-solving skills.
✨Showcase Your Collaborative Spirit
Since this role involves working closely with senior leadership and various teams, be prepared to discuss how you’ve effectively collaborated in the past. Highlight your communication skills and ability to build relationships, as these are key in a growing biotech environment.
