Senior Specialist, Development Supply Quality

Sr Specialist, Development Supply Quality

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 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.

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

You will be responsible for:

• Quality support to the PDCS team to ensure on time delivery of safe and compliant product for clinical trials associated with the management of temperature excursions.
• Works 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.
• Ensures Quality support and review of procedures associated but not limited to ISR (investigator sponsor research), comparators and home dosing.
• Quality oversight and approval of the pharmacy manuals, IRT protocol approval and build verification, SOP review and approval.
• Quality review of technical and quality agreements with clinical trial partners.
• Supports  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.

You will need to have:

• 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

We would prefer for you to have:

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

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.