Quality Control CTL Manager

📋 Description

• Manage QC Release and Stability testing at CTLs/CMOs, including scheduling and COA review.
• Lead method transfer and validation activities at CTLs/CMOs, incl. protocol reviews.
• Author and revise SOPs, forms, and docs for CTL management.
• Support CTL/CMO audits and quality system assessments.
• Collaborate with QC, QA, Manufacturing, and Supply Chain to improve processes.
• Drive continuous improvement to streamline lab workflows and ensure data integrity.

🎯 Requirements

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, or related field).
• 4–6 years of GMP analytical lab experience in a QC environment.
• Strong understanding of cGMP requirements and regulatory expectations for biotech/pharma QC operations.
• Experience with LIMS, electronic inventory systems, or sample tracking databases.
• Familiarity with stability programs and chain-of-custody workflows.
• Excellent communication skills and ability to work cross-functionally.
• Proficiency with MS Office and laboratory equipment software.