QC Manager

Work Location: Harris County, Texas

Summary:

Seeking a technical and operational leader to oversee analytical testing activities for clinical and commercial-stage cell and gene therapy programs. This role ensures compliance with regulatory standards, supports method qualification and validation, and leads a team in a fast-paced quality control laboratory environment.

Responsibilities:

• Supervise daily performance of analytical staff, ensuring effective execution of flow cytometry, molecular assays, and ELISA-based testing.
• Oversee data review, trending, and technical evaluation to maintain data integrity and compliance with regulatory requirements.
• Lead or support analytical method qualification and validation activities in accordance with industry guidelines.
• Facilitate the transfer of analytical methods from development to quality control and support lifecycle management.
• Participate in investigations, deviations, and CAPAs related to analytical testing, ensuring proper documentation and adherence to SOPs.
• Support regulatory inspections and audits as a subject matter expert for analytical platforms and maintain lab readiness.
• Assist with inventory management, laboratory organization, and compliance with quality and safety standards.
• Contribute to commercial-scale manufacturing readiness and perform additional duties to support departmental goals.

Qualifications:

• Bachelor’s degree in a scientific field or equivalent combination of education and experience.
• 7+ years of experience in a GMP quality control laboratory within cell and gene therapy or biologics manufacturing.
• Advanced expertise in flow cytometry analysis (panel design, gating strategy, data interpretation), molecular analytical methods (qPCR/ddPCR preferred), and ELISA assay execution and data interpretation.
• Experience supporting pivotal-stage or commercial readiness programs.
• Direct experience in analytical method qualification and/or validation under GMP standards.
• Strong understanding of data integrity, electronic systems, and regulatory expectations.
• Experience supervising or mentoring technical staff preferred.
• Capable of working in a fast-paced environment and communicating effectively with diverse teams.
• Experience supporting regulatory inspections (FDA, EMA) preferred.
• Experience with CAR-T or gene-modified cell therapy products preferred.
• Familiarity with analytical lifecycle management and assay robustness improvement preferred.
• Experience with LIMS or electronic data systems preferred.
• Strong technical troubleshooting skills and ability to interpret complex analytical datasets.
• Demonstrated leadership, team development, and cross-functional collaboration abilities.
• Regulatory and compliance mindset required.

Published Category: Quality & Validation