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.

PRIMARY RESPONSIBILITIES:

• 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.

EDUCATION:

• 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 protected].