Mgr., Biologics External Mfg. Quality (Hybrid)

Eisai•Cary, NC

3d•Hybrid

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Manager, Biologics External Manufacturing Quality provides quality oversight for Eisai’s biologics products manufactured at external partners (CMOs), covering Drug Substance (DS) and Drug Product (DP) including aseptic fill finish. The role ensures compliance with global GMP requirements and Eisai standards across product lifecycle, from cell banking and upstream/downstream processing through aseptic filling, packaging and release. The manager acts as Eisai’s Quality contact for assigned sites, driving batch disposition readiness, deviation/CAPA governance, complaint management and proactive risk management to safeguard patient safety. The position collaborates with supply chain, technical operations, and CMC Program Management to review and support approval of deviations, change controls, batch records, validation protocols, quality agreements, and regulatory documentation. The Manager assists with batch disposition and supports external audit activities.

Requirements

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

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.