Senior Manager, Quality Control

Job Summary

Leading Quality Control activities for small molecule GMP manufacturing, the full-time Senior Manager, Quality Control will oversee laboratory operations, product release, and regulatory compliance while ensuring data integrity and continuous improvement in a remote setting.

Key Responsibilities

• Manage day-to-day QC laboratory functions, including drug substance and drug product release testing
• Provide scientific leadership for analytical characterization and oversee method lifecycle management
• Maintain inspection readiness and support regulatory inspections while ensuring compliance with data integrity principles

Required Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline; Master's degree or PhD preferred
• 10+ years of experience in Quality Control or Analytical functions within small molecule pharmaceutical manufacturing
• 5+ years of people management experience, including leading managers and technical teams
• Strong understanding of small molecule analytical techniques and experience supporting regulatory filings
• Deep knowledge of OOS/OOT management, CAPA, change control, and data integrity expectations