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- Tasks: Lead and conduct GCP and GVP audits to ensure regulatory compliance.
- Company: Join a leading global pharmaceutical organisation committed to quality.
- Benefits: Competitive salary, professional development, and a collaborative international environment.
- Why this job: Make a real impact on global quality standards in clinical development.
- Qualifications: 5+ years in GCP/GVP auditing with strong regulatory knowledge.
- Other info: Opportunity for continuous improvement and cross-functional collaboration.
The predicted salary is between 36000 - 60000 £ per year.
AssureBio is supporting a leading global pharmaceutical organisation in hiring a Global GCP & GVP Quality Auditor to strengthen its global audit and inspection programme across Clinical Development and Pharmacovigilance. This role is ideal for an experienced GxP professional with a strong foundation in GCP and GVP auditing who thrives in a collaborative, international environment. You’ll lead and execute audits, support inspection readiness, and help maintain the highest levels of Quality and regulatory compliance across multiple GxP domains.
- Audit Leadership: Plan, conduct, and report GCP and GVP audits across investigator sites, CROs, vendors, and internal functions.
- Regulatory Compliance: Assess compliance with ICH-GCP, EU GVP, and relevant global regulations (FDA, EMA, MHRA).
- Inspection Readiness: Coordinate and support pre-inspection preparation and post-inspection follow-up activities.
- CAPA Oversight: Review audit findings, evaluate CAPA responses, and monitor completion to ensure effectiveness.
- Continuous Improvement: Identify systemic risks, drive process enhancements, and contribute to Quality Systems evolution.
- Cross-Functional Collaboration: Work closely with QA, Safety, Regulatory Affairs, and R&D to strengthen Quality culture and readiness.
Experience & Qualifications:
- 5+ years of experience in GCP/GVP auditing or Clinical/Pharmacovigilance Quality Assurance.
- Strong understanding of ICH-GCP, EU GVP, and international regulatory frameworks.
- Hands-on experience conducting and hosting audits and Health Authority inspections.
- Excellent analytical, reporting, and stakeholder management skills.
- Degree in Life Sciences, Pharmacy, or a related discipline (auditor certification preferred).
Global GCP & GVP Quality Auditor in England employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global GCP & GVP Quality Auditor in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the hunt for a Global GCP & GVP Quality Auditor role. You never know who might have the inside scoop on job openings 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 EU GVP regulations. Be ready to discuss how you've handled audits and inspections in the past, as well as your approach to CAPA oversight. Show them you’re the expert they need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills. Tailor your approach to each company to 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. Mention something specific from your conversation to show your genuine interest in the role and the company.
We think you need these skills to ace Global GCP & GVP Quality Auditor in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GCP and GVP auditing. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance in clinical development and pharmacovigilance. Let us know how you can contribute to our team!
Showcase Your Collaborative Spirit: Since this role involves cross-functional collaboration, share examples of how you've worked with different teams in the past. We love seeing candidates who thrive in a team environment!
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’s super easy!
How to prepare for a job interview at AssureBio
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of GCP and GVP regulations. Familiarise yourself with ICH-GCP, EU GVP, and the relevant global regulations like FDA and EMA. Being able to discuss these confidently will show that you're not just familiar with the terms but can apply them in real-world scenarios.
✨Showcase Your Audit Experience
Prepare specific examples from your past auditing experiences. Think about challenges you faced during audits and how you overcame them. This will help demonstrate your problem-solving skills and your ability to lead audits effectively.
✨Emphasise Collaboration Skills
Since this role involves cross-functional collaboration, be ready to discuss how you've worked with different teams in the past. Highlight any successful projects where you coordinated with QA, Safety, or Regulatory Affairs to enhance quality culture.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your analytical and decision-making skills. Practice how you would handle specific audit findings or CAPA responses. This will help you articulate your thought process and show your readiness for the role.
