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- Tasks: Lead QA activities in pharmacovigilance and ensure compliance across global operations.
- Company: Join a globally established pharmaceutical organisation focused on patient safety.
- Benefits: Competitive salary, professional development, and exposure to senior stakeholders.
- Why this job: Make a real impact on patient safety and regulatory compliance in a dynamic environment.
- Qualifications: Scientific degree and significant QA experience in pharmaceuticals or medical devices.
- Other info: Opportunity for career growth and continuous improvement in quality systems.
The predicted salary is between 60000 - 80000 £ per year.
AssureBio is supporting a globally established pharmaceutical organisation in the appointment of a GVP QA Manager to strengthen its R&D Quality Assurance function. This is a high-impact role focused on pharmacovigilance quality oversight, vendor governance and regulatory inspection readiness within a global environment. You will operate as a key Quality Subject Matter Expert, ensuring robust compliance, patient safety and proactive regulatory readiness across pharmacovigilance and wider GxP activities.
The position offers strong cross-functional exposure, working closely with senior stakeholders, global partners and regulatory bodies.
Key Responsibilities- GVP & R&D Quality Oversight
- Provide leadership across pharmacovigilance QA activities within R&D and Scientific functions
- Act as SME for GVP/GxP compliance and provide expert regulatory interpretation
- Maintain oversight of Pharmacovigilance System Master File (PSMF) integrity
- Support quality due diligence for new product opportunities
- Audit & Vendor Management
- Develop and maintain the R&D audit schedule
- Lead internal, vendor and third-party audits (acting as Lead or Co-Auditor)
- Oversee quality performance of PV vendors and service providers
- Ensure effective audit closure and CAPA tracking
- Inspection Readiness & Compliance
- Support regulatory inspection preparation and hosting (MHRA, EMA, FDA and global authorities)
- Lead CAPA management arising from inspections and audits
- Provide risk-based QA advice to cross-functional teams
- Review and approve deviations, change controls and quality events
- Quality Systems & Continuous Improvement
- Generate and present R&D quality metrics to senior stakeholders
- Deliver GxP training and guidance across the organisation
- Maintain awareness of evolving regulatory expectations and ensure business readiness
- Support continuous improvement of quality systems and processes
This role is central to ensuring high standards of pharmacovigilance compliance, vendor oversight and inspection readiness across a complex global environment.
Experience & Qualifications- Essential
- Scientific degree (Pharmacy, Chemistry, Biology, Engineering or related) or equivalent experience
- Significant QA experience within pharmaceutical and/or medical device environments
- Strong expertise in Good Pharmacovigilance Practice (GVP)
- Proven experience supporting regulatory inspections and PV teams
- Experience in auditing, CAPA management and quality systems oversight
- Ability to operate autonomously and make risk-based quality decisions
- Desirable
- Certification in auditing or Quality Systems Management
- Working knowledge of Good Clinical Practice (GCP)
- Experience managing PV vendors and service providers
- Strong stakeholder engagement and influencing skills
Candidates must demonstrate the ability to operate independently, provide strategic quality input and maintain strong regulatory compliance across global PV operations.
QA Manager - Inspections employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Manager - Inspections
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those involved in QA and pharmacovigilance. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your GVP knowledge and recent regulatory changes. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise and readiness.
✨Tip Number 3
Showcase your auditing skills! Bring examples of past audits you've led or participated in to the table during interviews. This will highlight your hands-on experience and ability to manage vendor oversight effectively.
✨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 QA Manager - Inspections
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Manager role. Highlight your experience in pharmacovigilance, auditing, and regulatory compliance. 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 the perfect fit for this role. Mention specific experiences that demonstrate your expertise in GVP and your ability to lead quality oversight. We love a good story!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just listing duties. Use metrics where possible to show how you’ve improved processes or ensured compliance. We appreciate candidates who can quantify their impact!
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 shows you’re keen on joining our team at AssureBio!
How to prepare for a job interview at AssureBio
✨Know Your Stuff
Make sure you brush up on Good Pharmacovigilance Practice (GVP) and any relevant regulations. Being able to discuss these topics confidently will show that you're not just familiar with the basics, but that you truly understand the complexities of QA in a pharmaceutical environment.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed audits, CAPA processes, or regulatory inspections. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewers to see your impact.
✨Engage with Stakeholders
Since this role involves working closely with senior stakeholders and global partners, be ready to discuss how you've effectively engaged and influenced others in your previous positions. Highlight your communication skills and any strategies you've used to build strong relationships.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality assurance and their expectations for the role. This not only shows your interest but also gives you a chance to assess if the company culture aligns with your values and work style.