QC Manager

Title: QC Manager

Location: Los Angeles

This is a hands-on leadership role within a fast-paced CDMO environment, overseeing all operations in the Quality Control laboratory. The ideal candidate will bring deep expertise in analytical chemistry, method validation, and sterile drug product testing, along with a strong track record of managing teams and driving continuous improvement.

Key Responsibilities

• Lead daily QC lab operations in compliance with cGMP and regulatory standards
• Manage and mentor lab staff, including training and performance development
• Develop and maintain robust training programs for technical proficiency
• Troubleshoot complex analytical and instrumentation issues
• Oversee method validation, instrument qualification, and lab investigations (OOS, deviations)
• Author, review, and approve SOPs, protocols, and investigation reports
• Ensure audit readiness and regulatory compliance
• Collaborate cross-functionally to support project goals
• Apply advanced analytical techniques (e.g., CE, ELISA)
• Promote a culture of continuous improvement and operational excellence

Qualifications

• Bachelor's degree in Chemistry or related field (required)
• 8+ years in pharmaceutical/biotech QC (7 years may be considered for exceptional candidates)
• 5+ years hands-on lab experience; 2+ years in a managerial role
• Strong experience with sterile drug product testing and CDMO operations
• Expertise in complex analytical methods and method validation
• Proven leadership in fast-paced, regulated environments
• Excellent problem-solving, communication, and organizational skills
• Experience in large pharma environments (preferred)

Additional Information

• This is a Quality Control-focused role (not QA)
• Candidates must have CDMO experience