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- Tasks: Design and implement a lean, inspection-ready Quality Management System for a growing biometrics CRO.
- Company: Dynamic biometrics-focused clinical services company with a collaborative pod-based model.
- Benefits: Flexible contract duration, competitive pay, and the chance to shape industry standards.
- Why this job: Make a real impact by building essential frameworks in a fast-paced environment.
- Qualifications: 8+ years in Clinical QA, experience building QMS, strong understanding of regulations.
- Other info: Opportunity to train internal teams and conduct mock audits for readiness.
The predicted salary is between 36000 - 60000 £ per year.
We are a growing biometrics-focused clinical services company building a pod-based delivery model. We are seeking an experienced Clinical QA consultant to design and implement a lean, inspection-ready Quality Management System aligned with ICH-GCP and industry standards.
The aim of this engagement is to:
- Design our QMS framework
- Develop core SOPs (governance, biometrics, compliance)
- Create templates, logs, and trackers
- Implement document control structure
- Train an internal team member to maintain the system
- Conduct a mock audit readiness review
Ideal Candidate:
- 8+ years in Clinical QA (CRO or Sponsor)
- Experience building QMS from scratch
- Strong understanding of ICH E6(R2), FDA regulations
- Experience supporting inspections
- Familiarity with biometrics (DM/Stats/Programming) preferred
We are looking for someone practical and strategic — not over-engineered, but inspection-ready.
Please include:
- Examples of QMS frameworks you have built
- Experience preparing companies for inspection
- Estimated timeline and availability
- Contract duration of 1 to 3 months, with 30 hours per week.
Mandatory skills: Good Clinical Practice, FDA, Clinical Trial, Regulatory Compliance, Qualitative Research, English.
Senior Clinical QA Consultant – Build GCP-Compliant QMS for Biometrics CRO employer: FreelanceJobs
Contact Detail:
FreelanceJobs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical QA Consultant – Build GCP-Compliant QMS for Biometrics CRO
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical QA field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and FDA regulations. We want to show that you’re not just experienced, but also up-to-date with the latest standards in the industry.
✨Tip Number 3
When you get an interview, be ready to discuss specific examples of QMS frameworks you've built. We love hearing about real-life experiences, so make sure to highlight your practical skills and strategic thinking.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Senior Clinical QA Consultant – Build GCP-Compliant QMS for Biometrics CRO
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in building QMS frameworks and preparing companies for inspections. We want to see how your skills align with our needs, so don’t hold back!
Showcase Relevant Experience: Include specific examples of QMS frameworks you've built and any relevant projects you've worked on. This is your chance to shine, so let us know how your background makes you the perfect fit for this role.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, especially when it comes to your estimated timeline and availability. Make it easy for us to understand your qualifications!
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at FreelanceJobs
✨Know Your QMS Inside Out
Make sure you’re well-versed in the Quality Management Systems you’ve built before. Be ready to discuss specific frameworks, SOPs, and how they align with ICH-GCP and FDA regulations. This will show your depth of knowledge and experience.
✨Prepare Real-Life Examples
Think of concrete examples from your past roles where you successfully designed or implemented a QMS. Highlight any challenges you faced and how you overcame them, especially in relation to inspection readiness and compliance.
✨Showcase Your Training Skills
Since part of the role involves training an internal team member, be prepared to discuss your approach to training. Share any methods or tools you’ve used in the past to ensure effective knowledge transfer and system maintenance.
✨Understand the Company’s Needs
Research the company’s current processes and think about how you can add value. Tailor your responses to demonstrate how your practical and strategic mindset aligns with their goal of building a lean, inspection-ready QMS.
