Senior Specialist, External Quality (12 month fixed term contract)

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

As a Senior Specialist for External Quality, you will provide essential oversight and support for quality activities related to tech transfer processes at contract manufacturing organizations (CMOs). You will ensure that quality standards are met for both clinical and commercial drug substance and drug product manufacturing. Your work will directly impact the success of tech transfer milestones and support ongoing quality assurance processes, including batch releases, change control, deviations, and CAPAs. All tasks must comply with company policies, procedures, and regulatory standards.

YOU WILL BE RESPONSIBLE FOR:

• Acting as the Quality leader with the Product Development/Clinical Supply (PDCS) teams, EM&O teams, and other stakeholders to ensure on-time delivery of tech transfer projects.
• Providing oversight of GMP systems completed by CMOs and the External Supply Chain function related to Drug Substance and Drug Product.
• Reviewing contractor documents, such as batch records, deviations, and change controls, to ensure compliance with organizational procedures and standards, and track implementation.
• Guiding ongoing reviews and approvals of documentation as applicable, and providing advice on GxP within the site, with reference to guidelines and regulations.
• Approving organization-specific standard operating procedures and controlled documents issued by contract manufacturing organizations, and supporting contract manufacturing organization audits, including pre-approval inspections.
• Developing and issuing quality metrics pertaining to the process quality activities, and actively engaging in process improvements and risk assessments.
• Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators, identify areas for continuous process improvements and risk mitigation, and propose and lead team implementation of appropriate CAPA.
• Reviewing and assessing deviations, including performing risk assessments, participating in root cause analysis investigations, and tracking, follow-up, and reporting/trending.
• Supporting Quality Assurance to guide various projects and technical meetings, as needed, and documenting and reporting compliance issues to management.
• Guiding early-career team members around quality processes, related digital tools, and compliance requirements.