At a Glance
- Tasks: Oversee quality assurance for external service providers in clinical trials and medical affairs.
- Company: Leading multinational pharma company based in London with a hybrid work model.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and compliance.
- Why this job: Join a dynamic team making a real impact on global health through quality assurance.
- Qualifications: 8+ years in Clinical Quality Assurance and strong regulatory knowledge required.
The predicted salary is between 60000 - 80000 £ per year.
PE Global is currently recruiting for an Associate Director, External Service Provider Quality Assurance for an 18 month contract role with a leading multinational Pharma client based in London (hybrid).
Responsibilities include:
- Review and approval of External Service Providers (ESPs) qualification for global clinical trials and medical affairs studies (RCs, PASS, NIS etc).
- Negotiation and execution of Quality Assurance Agreements (QAA) / quality terms with ESPs.
- Review and approval of external service provider Quality Risk Assessments (QRAs) to identify and evaluate various metrics, risks, trends, and potential quality and performance issues proactively.
- Ensure communication and support mitigation of actions for potential risks.
- Review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues.
- Support assessment of serious breaches and reporting to health authorities.
- Collaboration with business partners such as Global Medical Affairs, Vendor Partnership and Governance, Study Startup Organisation, Country Development Quality and Procurement to ensure their involvement in risk evaluation and timely communication to the business.
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.
- Ensure inspection readiness of local ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining to local ESP management.
- Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.
Qualifications:
- 8 years experience with Clinical Quality Assurance (e.g. involvement in clinical trial conduct).
- 4 years experience with Clinical Vendor Management.
- Experience working with Medical Affairs for Management of Research Collaboration, non-interventional studies, Real World Evidence etc.
- Strong understanding of regulations in the pharmaceutical industry.
Quality Associate/Manager employer: PE Global
PE Global is an exceptional employer, offering a dynamic work environment in the heart of London, where innovation meets collaboration. With a strong focus on employee growth and development, we provide comprehensive training and mentorship opportunities, ensuring that our team members thrive in their careers. Our hybrid work model promotes a healthy work-life balance, while our commitment to quality and compliance fosters a culture of excellence and integrity.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Associate/Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma industry, especially those who work in quality assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP, GLP, and GMP regulations. We want you to be able to discuss how you've handled quality issues in the past and how you can contribute to maintaining compliance.
✨Tip Number 3
Showcase your experience with Clinical Vendor Management. Be ready to share specific examples of how you've negotiated Quality Assurance Agreements or managed risks with external service providers.
✨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 Quality Associate/Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Associate/Manager role. Highlight your experience with Clinical Quality Assurance and Vendor Management, as well as any relevant regulatory knowledge. We want to see how your background aligns with what we're looking for!
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 the pharmaceutical industry. Share specific examples of how you've tackled quality issues or improved processes in your previous roles. We love a good story!
Showcase Your Collaboration Skills:Since this role involves working with various business partners, make sure to highlight your collaboration skills. Mention any experiences where you successfully worked with cross-functional teams or managed stakeholder relationships. We value teamwork at StudySmarter!
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 culture and values!
How to prepare for a job interview at PE Global
✨Know Your Quality Assurance Basics
Make sure you brush up on your knowledge of GCP, GLP, GVP, and GMP regulations. Being able to discuss these in detail will show that you understand the core principles of quality assurance in the pharmaceutical industry.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific quality issues or risk assessments. Think of examples from your past experience where you successfully identified and mitigated risks, and be ready to share those stories.
✨Familiarise Yourself with ESPs
Research common external service providers and their roles in clinical trials. Understanding their processes and how they fit into the bigger picture will help you articulate your thoughts during the interview.
✨Show Your Collaborative Spirit
This role involves working closely with various business partners. Be prepared to discuss how you've effectively collaborated with different teams in the past, and highlight your communication skills and ability to negotiate quality agreements.
