Head of Quality Control

Houston, Texas or London, UK

Job Title:  Head of Quality Control

Responsible to:  Chief Operating Officer



This individual will lead and drive overall QC strategy and management for Cell Medica ensuring required methods are developed, qualified, validated and maintained. This individual will possess a high level of scientific knowledge and innovation and have the capability to lead, structure and set-up the QC department.



  • Drive overall QC strategy and management in partnership with Manufacturing and Research & Development to ensure required methods are developed, qualified, validated and maintained.
  • Develop in-process and final specifications for Cell Medica’s cell therapy products
  • Establish specifications and testing process of raw materials
  • Lead QC to consistently maintain high level of scientific knowledge and innovation while maintaining GMP compliance.
  • Establish strong links with external manufacturing and process development, and validation contractors and closely monitor their QC operations and output.
  • Act in the capacity of technical expert for analytical methodologies to be able to resolve quality control issues and implement timely resolution. Monitor and trend in-process and final product analytical results to support quality improvements and risk management.
  • Lead high performing scientific team members in developing and managing a state of the art GMP compliant Quality Control Laboratory
  • Responsible for chemical, biochemical, biological and microbiological testing including raw materials to be utilized in cell therapy manufacturing, release and monitoring of patient samples
  • Develop and manage QC budget plans, maintenance of testing procedures, assay controls and standards.
  • Accountable for QC personnel staffing, their training and performance consistent with requirements of GMP compliant operations.


Education and Experience

  • PhD in cell/molecular biology or associated sciences
  • Experience in gene/cellular therapy field, preferably in a GMP environment, where the candidate has demonstrated leadership in the field of QC and analytical process development and validation
  • 10+ years’ experience in leading/managing teams, in both analytical and quality control operations
  • Experience in analytical method development and validation in a cGMP environment to support clinical and commercial programs
  • Knowledge of the current state of the art in cell product analytical development and instrumentation, developments and future trends in the field.
  • Capability to build a QC department
  • Experience in management of outsourced activities at CMOs
  • Experience in face-to-face communications with regulatory agencies and in-depth knowledge of GMP regulations in the US and/or Europe.


Personal Attributes

  • Strong project management skills superb organizational, analytical, and communication skills and “do-what-it-takes” attitude
  • Strong planning and resource management skills in a dynamic project environment
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual able to work with limited direction in a fast-paced, goal-oriented environment
  • Must be able to remain in a stationary position 50%
  • Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.



This job description is subject to change at any time.

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