Lead Quality Advisor, Clinical Supply Quality
Location: UK (Macclesfield)
Type: Permanent
Competitive Salary & Benefits
Be proud to play a significant role to bring safe and effective new medicines to patients. We are adventurous, agile and pragmatic to enable our business to use innovative solutions and technologies to supply clinical trial materials to patients.
Business area
In the Clinical Supply Quality Team, we are responsible for quality in the development of new Clinical Trials and collaborations and the supply of Investigational Products to them. With a portfolio encompassing both small and large molecules, combination products and ground-breaking technologies we are providing novel life-changing medicines to our patients around the globe.
We work collaboratively are part of Development Quality with teams across three countries spanning all Quality activities required for development of new medicines.
We have an exciting opportunity to join the Clinical Supply Quality team in the Lead Quality Advisor role.
Description:
The Lead Quality Advisor in Clinical Supply Quality is the prime source of quality/compliance advice to the Clinical Supply organization. They interpret external regulatory standards and expectations into appropriate quality standards and provide mentorship to the Clinical Supply organization and supply chain teams to ensure overall that compliance with AstraZeneca and Regulatory requirements are met.
What you’ll do:
- Support Supply Chain design and set up for global clinical studies working with a variety of sources of investigational product
- Develop solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought, strategic vision and analysis.
- Maintain own regulatory knowledge and collaborate with colleagues to share insights and knowledge
- You will work collaboratively as part of a team of Quality professionals including other UK and EU QPs
- Mentor, support and encourage junior colleagues for enhanced individual and team performance
- Provides appropriate Quality input to major Clinical Supply business improvement projects and may lead projects across the Development functions.
- Lead the delivery of Quality activities and inputs for innovation and improvement projects.
- Interpret external regulatory standards and expectations and lead gap analysis and implementation of updates based on new and changed regulatory requirements.
- Contribute to Supply Chain, cross-Quality and Clinical Supply Quality projects with expertise and delivery. This may include all Quality aspects of projects including IT projects.
- Support Clinical Supply functions in GMP inspections and input to GCP inspections where required
- Approve Clinical Supply GMP documentation
- Contribute to release and other routine activities required in the clinical supply chain
- Support quality events including major quality events involving supply chain issues
- Operate as part of a global organisation with an integrated attitude to build an organisation with common processes and ways of working.
- Drives, role models and supports a strong lean culture that promotes standardisation, simplification and continuous improvement
Essential Requirements – Education and Experience Functional & Business Knowledge
- Extensive experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
- Extensive experience from working in a Quality Assurance function is essential;
- A broad and comprehensive understanding of Quality Systems and GMP
- A comprehensive understanding of the pharmaceutical/drug development process
- Good knowledge and reputation in the QA arena and specifically in GMP matters
- Understanding of Project Management and Supply Chain processes
Skills and Capabilities
- Excellent team working, networking skills and encouragement of team efficiency
- Demonstrates independent judgement and uses risk management in complex situations
- Capable of making decisions, acting courageously and communicating with conviction and inspiration
- Demands excellence (sets high bar) and delivers
- A good communicator with experience of interacting effectively across interfaces
- Builds excellent relationships both internally and with external suppliers or service providers
- Demonstrates drive and energy in the role to make a difference.
- Demonstrates a high degree of personal credibility
Desirable Experience/Skills
- Eligible to act as a Qualified Person in accordance with Schedule 7 of UK SI 2012/1916 (the Human Medicines Regulations 2012), or a trainee Qualified Person.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.
Why AstraZeneca...
It’s a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like new modalities. Our continued growth gives you greater exposure than anywhere else.
So, what’s next...
Are you already imagining yourself joining our team? Great, because we can’t wait to hear from you!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.