Eisai US · 1 day ago
Mgr., Biologics External Mfg. Quality (Hybrid)
Cary, NC
Full-time
Hybrid
Mid, Senior Level
$105K/yr - $138K/yr
5+ years expEisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. The Manager, Biologics External Manufacturing Quality is responsible for providing quality oversight for biologics products manufactured at external partners, ensuring compliance with global GMP requirements and Eisai standards throughout the product lifecycle.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Review and approve batch records for DS and DP manufacturing, ensuring compliance and data integrity
Assess and approve deviations, investigations, and CAPAs related to DS and DP operations (e.g., EM excursions, media fill failures, process deviations)
Oversee change controls impacting DS and DP processes
Support batch disposition activities to ensure timely and complaint product release
Monitor and track manufacturing data for integrity and compliance
Ensure CMO compliance with quality systems (change control, deviations, investigations, OOS results, validation, retain sample management)
Contribute to evaluation of product complaints and regulatory compliance of CMOs
Review technical protocols, reports, batch records, and regulatory documentation related to DS and DP manufacturing and validation activities
Support development and maintenance of processes and procedures governing quality systems and CMO interactions
Collaborate with internal and external stakeholders to drive compliance, continuous improvement and risk mitigation across external manufacturing operations
Qualification
Required
Education: BS/BA in life sciences or engineering (required); advanced degree desirable
Experience: 5+ years of Quality experience in biologics DS and DP operations, including aseptic fill-finish
Knowledge of EU GMP Annex 1 & Annex 2, FDA aseptic guidance, and global sterility assurance principles
Experience with DS processes (cell culture, purification) and DP aseptic operations (media fills, EM trending, contamination control strategies)
Understanding of Quality System Management (lot disposition, deviations, change management, complaints)
Strong organizational and communication skills; ability to manage multiple priorities
Proficiency in Microsoft Office tools
Ability to travel up to 25% (domestic and international)
Required onsite Tuesday-Thursday
Benefits
Eisai Inc. Annual Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1001-5000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP & Head of Office, Government Affairs & Policy
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