More jobs:
Biologics QC Strategy Lead Global Submissions
Job in
Augusta, Kennebec County, Maine, 04338, USA
Listed on 2026-07-17
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-17
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Manager, Quality Control (Biologics) to oversee QC activities across CDMOs and contract labs in a virtual model, ensuring analytical testing for biologics meets cGMP and regulatory standards.
You will lead method transfers and lifecycle management, ensure data integrity, support IND/BLA/MAA submissions, and collaborate across Analytical Development, QA, Regulatory Affairs, and Supply Chain.
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