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.
This individual will manage a team of Manufacturing Quality Associates and provide Quality leadership and support in maintaining GMP Compliance during in-house/CMO based manufacturing Campaigns of BDS/ADI.
Serve as a primary Quality Assurance resource for the Biologics Pilot Plant Operations team and will advise on GMP compliance during Manufacturing Campaigns and related activities.
Provide Quality oversight to the GMP Deviations and Non-Conformances, Change Control and CAPA management, serve as lead on Root cause Investigations, and resolution to Product Quality issues, Training and mentoring of Quality Assurance staff, as needed.
The Senior Quality Manager will also manage, External and Internal Audit Programs, Supplier Qualification and monitoring Program, Contract Organizations (COs) management in support of BPP activities, and Data Integrity Compliance.
The Senior QA Manager will promote culture of Quality & guide manufacturing team to ensure compliance with cGMPs, EMEA, ICH, and JP regulations.
Provide Quality oversight and leadership within the Biologics Pilot Plant (BPP) Operations & Manufacturing Support (Including Quality Control) departments in the execution of key quality systems, and ongoing Continuous process improvement.
Provide quality lead in Compliance management during Manufacturing Campaigns at BPP, of DS/ADI in Up-stream/Downstream Processes, Production Support processes, such as (but not limited to) Manufacturing Process controls, Deviation/Non-conformance, Root-Cause Investigations and CAPA Management; and Change Management activities.,
Review and Approval of Specifications, Sampling Plans, Test Methods, Master Batch Records/Executed Batch Records, Analytical /Biological Test data Package for Manufacturing and DS/ADI Disposition
Provide QA oversight on GMP Manufacturing Processes, Environmental/Contamination Control, Cleaning and Housekeeping, and Pest Control Program.
Monitoring Manufacturing Campaigns at Contract Organizations (COs), Review and approval of Batch records, Specifications, Change Controls, Deviations and CAPAs.
Represent Eisai Quality as a Quality lead in new Product Development Project (s) assigned and will play a lead role in Quality Planning and support in defining Process Validation Strategy for new products.
Work with the site Quality Team to execute Quality Plan Activities related to CMC Product Development
Ensure adherence to phase Specific cGMP compliance during CMC development activities as per Eisai Exton quality system requirements, establish materials specifications and Acceptance Criteria in compliance with FDA, EMEA, JP regulations, and ICH guidelines.
Review existing and Implement new Policies/Procedures as needed for site commercial readiness
Participate in Internal and external audits to perform Gap assessment in the existing quality Systems and provide support in closing the GMP Gaps identified during the Internal/External/Regulatory Audits.
Provides Quality review of Product Regulatory Dossier and CMC documentation.
Play a leading role in site Inspection readiness, Pre-approval Inspection, and commercial launch readiness.
Bachelor-level degree in Biological Sciences/Biotechnology or related subjects is required, Graduate level degree preferred.
8+ years’ experience in Quality Management with at least 3 years in management or supervisory role in a GMP Manufacturing Environment.
Knowledge and experience of Product Quality Management Aseptic Manufacturing processes, and GMP Compliance in Manufacturing Environment. Previous experience of working in a biologics/biopharmaceutical manufacturing facility is desired.
Experience of Batch Records Review, Product Disposition, Root-Cause Investigations, and Change Implementation in manufacturing environment.
Must have knowledge of FDA, EMEA, and JP regulations as they pertain to GMP Manufacturing including bulk drug substance, drug product, filling, packaging, distribution, and analytical testing as related to the development of antibody-based bio-therapeutics.
Problem-solving and decision-making skills and the ability to prioritize and successfully manage complex and competing projects are required
Working knowledge of standard industry IT solutions (i.e., LIMS, SAP, Trackwise) is preferred.
Knowledge of Pharmaceutical Product Development Processes, Production Process Controls, Data Integrity, and Risk Assessment and supplier Quality is a Plus.
Manage Data Integrity Risk Management Program
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.