Biologics QC Senior Manager – Global Submissions
Job in
Nashville, Davidson County, Tennessee, 37247, USA
Listed on 2026-07-11
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
The Senior Manager, Quality Control (Biologics) will execute and support QC activities across CDMOs and contract testing labs within a virtual operating model, ensuring all analytical testing for biologics drug substance and drug product meets cGMP, regulatory, and company standards.
This role oversees QC interface with external partners, supports analytical strategy, method lifecycle management, and data integrity, contributing to IND/BLA/MAA submissions and global regulatory filings.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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