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
KEY SKILLS and COMPETENCIES:
- 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 email@example.com.