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Senior Manager, Quality Control (Small Molecules)

Company

Otsuka

Location

United States, United States

Posted

July 21, 2026

Position Overview

The Senior Manager, Quality Control (Small Molecules) will execute and support the strategic and operational leadership for Quality Control activities supporting small‑molecule GMP manufacturing, product release, and regulatory compliance. This role is responsible for overseeing QC laboratory operations, drug substance and drug product release, analytical characterization, and regulatory readiness while ensuring robust data integrity, inspection readiness, and continuous improvement across the product lifecycle.

Key Responsibilities

Quality Control Operations & Product Release

  • Manage day-to-day QC laboratory functions supporting small‑molecule drug substance (DS) and drug product (DP) release, including raw materials, in‑process testing, stability, and finished product testing.
  • Supports QC batch disposition and release testing, ensuring alignment with approved specifications and regulatory filings.
  • Ensure e...
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