Senior Specialist, Development Supply Quality

As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory, and Safety stakeholders. You will achieve this through learning, embedding a quality mindset, and executing continuous improvement opportunities. You will support key process/system improvements in collaboration with Development, Regulatory, and Safety functions, Development Quality peers, and other Quality colleagues. Additionally, you will provide quality oversight and support to the Global Clinical Supply (PDCS) team to ensure compliance with GMP (good manufacturing practices) for product distribution and GCP (good clinical practices) in the supply of products to clinical sites.

Accountabilities

• Provide quality support to the PDCS team to ensure on-time delivery of safe and compliant products for clinical trials associated with the management of temperature excursions.
• Work with the PDCS team to ensure on-time commitments for quality oversight linked to risk management, change control implementation, deviation/investigation review, and associated CAPAs.
• Ensure quality support and review of procedures associated but not limited to ISR (investigator sponsor research), comparators, and home dosing.
• Oversee and approve pharmacy manuals, IRT protocol approval and build verification, SOP review, and approval.
• Conduct quality reviews of technical and quality agreements with clinical trial partners.
• Support quality issues including audit-related CAPAs, quality issues/incidents CAPA development, working closely with the audit team, Development, Regulatory, and Safety functional lines along with PDCS.

Essential Skills/Experience

• Bachelor’s or Higher Degree in life sciences or similar scientific subject
• 3+ years experience in quality assurance, including GCP and GMP areas
• Experience in process improvement and project management
• Problem-solving and analysis skills; ability to see trends and convert information to insights
• High attention to detail and accuracy
• Excellent communication skills; fluent oral and written English

Desirable Skills/Experience

• Good analytical, problem-solving, and negotiation skills
• Experience in working in a global role
• Cultural Awareness and Positive attitude in managing change

At AstraZeneca's Alexion division, you will join a company where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. Grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. Here, your career is not just a path but a journey to making a difference where it truly counts.

Ready to make an impact? Apply now!

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.