Senior Quality Control Manager

Job Summary

Responsible for overseeing contract manufacturing organization (CMO) quality control labs, the full-time Senior Quality Control Manager will establish internal QC processes, maintain control strategies for investigational products, and support analytical control strategies for clinical products in a remote setting.

Key responsibilities

• Collaborate with Analytical Development to support analytical control strategies and ownership of product specifications
• Develop and maintain the stability program, including trend monitoring and statistical evaluation practices
• Manage validation and qualification of analytical methods to support multi-phase clinical trials

Required qualifications

• Bachelor's degree in Biology, Biochemistry, Chemical Engineering, or Biotechnology
• 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years overseeing cell therapies contract labs
• Experience with method transfer from Analytical Development to QC and external labs
• Expertise in cGMP analytical requirements and regulatory regulations for biopharmaceutical products
• Demonstrated ability to manage laboratory personnel in a GMP setting, including training and procedure establishment