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 subject3+ years experience in quality assurance, including GCP and GMP areasExperience in process improvement and project managementProblem solving and analysis skills; ability to see trends and convert information to insights.High attention to detail and accuracyExcellent communication skills; fluent oral and written English

We would prefer for you to have:

Good analytical, problem-solving and negotiation skillsExperience in working in a global roleCultural 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

Date Posted

31-Jan-2025

Closing Date

13-Feb-2025

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.