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Biologics QC Strategy Lead Global Submissions

Job in Concord, Merrimack County, New Hampshire, 03306, USA
Listing for: Otsuka America Pharmaceutical Inc.
Full Time position
Listed on 2026-07-17
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Salary/Wage Range or Industry Benchmark: 134615 - 201250 USD Yearly USD 134615.00 201250.00 YEAR
Job Description & How to Apply Below
Position: Biologics QC Strategy Lead for Global Submissions

Otsuka America Pharmaceutical Inc. seeks a Senior Manager, Quality Control (Biologics) to lead QC activities across a virtual model with CDMOs and contract labs in the United States.

You will oversee analytical strategy, data integrity, and lifecycle management while supporting IND/BLA/MAA submissions and global regulatory expectations. The role requires strong experience in biologics QC, regulatory filings, and cross-functional leadership to ensure cGMP compliance and audit readiness in a

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