This is what you will do:
The Senior Manager for QualityOperationswillbe responsible forleading andproviding oversight of quality activities associatedwith drug substance/drug producttechnical transfer processes at contract manufacturing organizations (CMOs).The Senior Managerdrivesthe completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of Contract Manufacturing oversight,ensuring compliance with GMP in the supply of commercial and clinical product.Provide Quality service and guidance to various stakeholders.Execute strategies tocontrol, andimprove quality partnering with peers and influencing stakeholders to successfullyembed a strong Quality culture.Identify, evaluate, and drive the remediation of quality risks and quality issues in collaboration with peers in Alexion’s portfolio.
You will be responsibleto:
This position will report to Director of QualityOperations. Duties included but not limited to:
Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators,identifyareas for continuous process improvements and risk mitigation, and propose and lead team implementation ofappropriate CAPA.
Provides oversighttocontinuous quality system improvements and supports implementing improvements atCMO's incompliance, Preventive Maintenance, Deviation Management and Change Control Programs as theyimpactAlexion.
Works closely with internal cross-functional impacted areas, such as EM&O, RegulatoryAffairs,TechnicalServices, Product Development/Clinical Supply to resolve open issuesin a timely mannerresulting from record reviews and deviation events.
Reviews and assesses deviations; includes performing risk assessments,participatingin root cause analysis investigations, tracking,follow-upand reporting/trending.
Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with ateam orientedapproach.
Experience providing QA oversight across end-to-end technical transfers for biologics—reviewing/approving transfer plans and protocols, ensuring CPPs/CQAs are aligned and compliant. Supporting engineering and PPQ runs including associated deviations, CAPA, and change controls.
Activelylearnsabout the industry, products,marketand regulatory landscape.Caninterpret implicationson ownarea and guide teams around regulatory documentation,applicationsand review.
Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.Creates actionable work plans for own areas, accounting for dependencies across different teams.
We wouldprefer foryou to have:
Education/Minimum Years Industry Experience:
Date Posted
18-Feb-2026
Closing Date
03-Mar-2026Our 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.