At a Glance
- Tasks: Oversee quality assurance for external service providers in global clinical trials.
- 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 healthcare quality standards.
- Qualifications: 8+ years in Clinical Quality Assurance and strong regulatory knowledge required.
The predicted salary is between 70000 - 90000 £ 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.
- 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.
- 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.
- 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 inspections.
- Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes.
Requirements:
- 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.
- Strong understanding of regulations in the pharmaceutical industry.
Quality Management Associate Director employer: PE Global
PE Global is an exceptional employer, offering a dynamic work environment in the heart of London, where innovation meets collaboration. As a Quality Management Associate Director, you will benefit from a hybrid working model, competitive remuneration, and opportunities for professional growth within a leading multinational pharmaceutical company. Our culture prioritises employee development, ensuring you are equipped with the skills and support needed to excel in your role while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Management Associate Director
✨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 ready to discuss how your experience aligns with the responsibilities of the role, especially around risk assessments and quality metrics.
✨Tip Number 3
Showcase your collaboration skills! Be ready to share examples of how you've worked with cross-functional teams in the past. Highlighting your ability to communicate effectively with business partners will set you apart.
✨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 Management Associate Director
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Associate Director, External Service Provider Quality Assurance. Highlight your experience in 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 the perfect fit for this role. Mention specific experiences that relate to the responsibilities outlined in the job description, like your work with quality risk assessments or negotiation of Quality Assurance Agreements. We love a good story!
Showcase Your Collaboration Skills:Since this role involves working closely with various business partners, make sure to highlight your collaboration skills. Share examples of how you've successfully worked with teams in the past, especially in relation to quality management and compliance. 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 us and what we stand for. We can’t wait to hear from you!
How to prepare for a job interview at PE Global
✨Know Your Stuff
Make sure you brush up on your knowledge of Clinical Quality Assurance and the specific regulations in the pharmaceutical industry. Familiarise yourself with GCP, GLP, GVP, and GMP guidelines, as well as the role of External Service Providers in clinical trials. This will show that you're not just a candidate, but someone who understands the landscape.
✨Showcase Your Experience
Prepare to discuss your past experiences in Clinical Vendor Management and Medical Affairs. Be ready to share specific examples of how you've handled quality issues or risk assessments in previous roles. This will help demonstrate your capability to manage the responsibilities outlined in the job description.
✨Collaboration is Key
Highlight your ability to work with various business partners. Think of examples where you've successfully collaborated with teams like Global Medical Affairs or Procurement. This will illustrate your teamwork skills and your understanding of the importance of communication in quality assurance.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to quality issues or risk management. Prepare by thinking through how you would approach these scenarios, focusing on proactive communication and mitigation strategies. This will showcase your problem-solving skills and readiness for the role.
