Introduction to role
Are you ready to take on a pivotal role in shaping the future of pharmaceutical development? As an Associate Director in Development Quality, we'll need you at the forefront of ensuring compliance and excellence in our dynamic Research & Development environment. This is your chance to apply your expertise and leadership skills to make a significant impact on the quality of life-changing medicines.
Accountabilities
1. Provide expert support and guidance to satisfy external Regulatory Authority GMP inspections and support implementation of agreed global standards.
2. Develop and contribute to the internal audit plan and host external inspections
3. Owner of a number of Quality Management systems/processes and lead continual improvement of these systems in line with new GMP regulations.
4. Provide GMP advice to support internal manufacturing and laboratory activities.
5. Responsible for QA approval of documentation and Quality records to ensure GMP compliance
6. Interpret, trend and report compliance data to measure and improve quality standards
7. Develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to their area.
8. Mentor, support, and inspire junior colleagues for enhanced individual and team performance.
9. Ensure appropriate Quality Assurance input to major business improvement projects and lead projects across Pharmaceutical Development.
10. Drive, role model, and support a strong lean culture that promotes standardisation, simplification, and continuous improvement.
Essential Skills/Experience
11. Appropriate scientific degree with extensive experience of working within a pharmaceutical GMP environment
12. Extensive experience from working in a Quality Assurance function is critical
13. A broad and comprehensive understanding of Quality Systems and GMP
14. A comprehensive understanding of the pharmaceutical/drug development process
15. Understanding of Project Management and Supply Chain processes
16. Excellent team working and networking skills and encourages team effectiveness
17. Demonstrates independent judgement and uses risk management in complex situations
18. Capable of making decisions, acting courageously, and communicating with conviction and inspiration
19. Demands perfection (sets high bar) and delivers drive and energy in the role to make a difference
20. A good communicator with experience of interacting effectively across interfaces. Building excellent relationships both internally and with external suppliers or service providers
21. Ability to develop solutions to a wide range of problems that require complex judgements
Desirable Skills/Experience
22. Qualified Person eligible
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions.
That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, you'll find yourself immersed in a collaborative environment where innovation thrives. Working alongside a global team on diverse projects, you'll be exposed to new ideas that foster growth both individually and collectively. Here, every voice is valued, creating an inclusive atmosphere where you can truly make a difference.
Ready to take the next step in your career? Apply now to join our team at AstraZeneca!
Date Posted
11-Sept-2025
Closing Date
25-Sept-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.