Cold-Chain Manager – Quality Assurance

TITLE: Cold Chain Manager – Quality Assurance

REPORTS TO: VP, High Value Services

JOB PURPOSE: Establish, implement and manage the company’s Cold-Chain Quality Program. Provide knowledge, experience and training to drive Cold-Chain excellence throughout the organization. Develop and implement industry best practices to achieve and maintain cGMP standards compliance.


  • Ensures Cold-Chain quality assurance system is in place that meets all required regulations.
  • Develop processes and manages all documentation for Cold-Chain quality assurance program, including but not limited to: standard operating procedures, training documentation, corrective actions, change control, equipment qualification and software validations.
  • Establish and maintain standards for trailers, calibration, validation and mapping protocols.
  • Provides oversight for all equipment mapping, validation and equipment calibration.
  • Define roles and responsibilities for all employees involved in Cold-Chain process.
  • Responsible for compliance and to drive the execution of all Cold-Chain quality assurance processes to ensure an efficient and effective Cold-Chain operation.
  • Hosts and facilitates all audits performed by clients.
  • Ensures all internal audits are performed per schedule and all findings are communicated with department managers and senior management.
  • Audit and qualify any vendors that are utilized for Cold-Chain services.
  • Responsible for coordinating the investigation of any Cold-Chain quality complaint and report the results and the corrective action.
  • Manages the department resources to execute the Cold-Chain quality assurance program and support the daily operations.


  • Minimum High School Diploma
  • Bachelor’s degree preferred
  • Knowledge of cGMP, PDA, 21 CFR and understanding of Quality Systems
  • Knowledge of ISO 9001 requirements


  • Strong communication, organizational and customer service skills.
  • Strong attention to detail, follow through and the ability to communicate and control activities through third party providers.
  • Ability to write, and maintain Cold-Chain SOPs
  • Effective analytical and project management skills.

To apply, please email