POSITION TITLE: QC ManagerLocation: Houston, TX Onsite
Department: Quality Control
Reports to: Associate Director, Quality Control
Key Responsibilities:The QC Manager will provide technical and operational oversight for analytical testing activities supporting clinical and pivotal-stage Cell and Gene Therapy (CGT) programs transitioning toward commercial readiness. This role will lead testing execution, ensure compliance with GMP requirements, and support method qualification and validation activities for advanced analytical platforms including flow cytometry, molecular assays, and ELISA.
The ideal candidate is a strong technical leader with demonstrated expertise in flow cytometry data analysis, molecular testing methodologies, and ELISA platforms within CGT manufacturing environments.
- Provide day-to-day supervision of QC analytical staff performance:
- Flow cytometry analysis (multicolor panels, CAR detection, phenotyping, functional assays).
- Molecular assays (e.g., qPCR/ddPCR, vector copy number, gene expression)
- ELISA-based potency and cytokine assays
- Ensure testing activities support clinical Phase I/II, pivotal, and commercial readiness programs.
- Oversee data review, trending, and technical evaluation to ensure data integrity and compliance with 21 CFR Part 211 and Part 11 requirements.
- Lead or support analytical method qualification and validation activities per ICH guidelines
- Support transfer of analytical methods from Development to QC.
- Participate in investigations, deviations, OOS/OOT events, and CAPAs related to analytical testing.
- Ensure proper documentation practices and adherence to internal SOPs and regulatory standards.
- Support regulatory inspections and client audits as SME for analytical platforms.
- Contribute to readiness for commercial-scale manufacturing and lifecycle management.
- Perform daily lab tasks and support adherence to production and testing schedules.
- Assist in the execution of method, equipment, and process validation/qualification activities in accordance with ICH guidelines, cGMP, cGTP, and other applicable regulatory standards.
- Support reference standard characterization and data trending.
- Ensure lab readiness for internal and external audits by maintaining compliance with regulatory and quality standards.
- Assist with inventory management to support uninterrupted laboratory operations.
- Maintain general laboratory organization, cleanliness, and compliance with 5S principles.
- Perform other duties as assigned to support department and company goals.
Qualifications/Skills- Bachelor's degree in science field required or equivalent combination of education and experience.
- 7+ years of experience in GMP QC laboratory within Cell and Gene Therapy or biologics manufacturing.
- Advanced experience in:
- Flow cytometry analysis (panel design, gating strategy, data interpretation)
- Molecular analytical methods (qPCR/ddPCR preferred)
- ELISA assay execution and data interpretation
- Demonstrated experience supporting pivotal-stage or commercial readiness programs.
- Direct experience in analytical method qualification and/or validation under GMP.
- 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 a diverse work group.
Preferred Experience- Experience supporting regulatory inspections (FDA, EMA).
- Experience with CAR-T or gene-modified cell therapy products.
- Familiarity with analytical lifecycle management and assay robustness improvement.
- Experience with LIMS or electronic data systems.
Core Competencies- Strong technical troubleshooting skills
- Ability to interpret complex analytical datasets
- Leadership and team development
- Regulatory and compliance mindset
- Cross-functional collaboration (QA, AD, Manufacturing)
Working Conditions, Equipment, Physical Demands The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:
Equipment-
- Computer
- Printer
- Scanner
- Telephone
- Lab Equipment
Physical Demands-
- Frequent sitting, standing, walking
- Carrying packages and moving bins and boxes, lifting up to 10 lbs.
The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary. 
