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
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