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: Dynamic role with exposure to end-to-end QMS build.
- Why this job: Join at a pivotal moment and make a real impact on clinical development.
- Qualifications: Experience in GCP QA and early clinical studies required.
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
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) 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, all while contributing to meaningful advancements in healthcare. This role offers a unique chance to make a significant impact during a critical phase of clinical development, ensuring your contributions are both valued and rewarding.
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 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 brushing up on your GCP knowledge and understanding the specific challenges faced by early clinical studies. Be ready to discuss how your experience aligns with the company's needs. Show them you're the perfect fit!
✨Tip Number 3
Don’t just apply through job boards; head over to our website and submit your application directly. This way, you can showcase your enthusiasm for the role and stand out from the crowd!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Use this opportunity to reiterate your interest in the role and highlight any key points from your conversation.
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 relevant experience in biotech or pharma, especially around GCP and early clinical studies. We want to see how your background aligns with what we're looking for!
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved QMS frameworks or successfully conducted audits. This helps us see the impact you've made in previous roles.
Keep It Professional Yet Personal:While we appreciate professionalism, don’t be afraid to let your personality shine through. A bit of warmth and authenticity can make your application stand out. Remember, we’re looking for someone who fits into our innovative culture!
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 the role. Plus, it shows us you're keen on joining our team!
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, especially those related to early clinical studies. This will show that you’re not just familiar with the theory but have practical insights to offer.
✨Showcase Your QMS Experience
Prepare to talk about your experience in building or improving Quality Management Systems (QMS). Think of concrete examples where you’ve streamlined processes or developed SOPs. This will demonstrate your ability to contribute effectively to their quality framework.
✨Be Ready for Audit Scenarios
Since the role involves conducting audits, be prepared to discuss your audit experiences. Think about challenges you faced during audits and how you overcame them. This will highlight your problem-solving skills and your hands-on approach.
✨Emphasise Adaptability
This position requires working autonomously in a fast-paced environment. Share examples of how you've successfully adapted to changing circumstances in previous roles. This will reassure them that you can thrive in their evolving biotech setting.
