The Senior Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations including technology transfers within the External manufacturing realm. The Senior Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA's. Performs’ all responsibilitiesin accordance withcompany policies, procedures, and regulations.
Principal Responsibilities:
Serving as Quality Assurance support and SME for Drug Substance, Drug Product andmaintainingknowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
Providing oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as theyimpactAlexion
Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issuesin a timely mannerresulting from record reviews and deviation events
Reviewing and assessing deviations; includes performing risk assessments,participatingin root cause analysis investigations, tracking,follow-upand reporting/trending
Date Posted
20-Jan-2026
Closing Date
26-Jan-2026
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