Quality Manager

SUMMARY     The Quality Manager manages the daily operations of the company’s Quality department to meet business, GMP and regulatory requirements.

The Quality Manager is responsible for managing the daily operations of the department in compliance with CFR 111 regulations while supporting activities in Operations, Procurement, and other departments.

The role ensures the effectiveness and continuous improvement of the quality management system and directs site Quality staff.     ESSENTIAL FUNCTIONS  Manage and perform the evaluation of purchased raw materials, in-process testing, and finished goods for final batch disposition  Maintain the Company’s quality management system by providing oversight and input  into the relevant quality systems and standards including  Change control  Documentation systems  Quality procedures  Standards, and policies  Product complaint management  Internal and external audit programs  Corrective Action and Preventative Action  Material Review Boards  Vendor Risk Management  Calibrations and maintenance  Equipment and computer system validation and commissioning  Hire, manage, and develop Quality department staff and support the company’s goals and objectives  Set and communicate priorities to staff  Ensure continuous improvement and effectiveness of the quality management system  Assist in the development and implementation of standards, methods and procedures  for testing and inspection of ingredients, packaging material components, and finished products  Collect, analyze and summarize information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations  Provide support to the daily operations of Quality department  Perform final review and approval of records, documentation, and reports   Manage and support third party inspections and audits and follow up activities  Develop, manage, and deliver training plans for Quality department personnel Perform maintenance, data entry, and analysis in various electronic systems utilized by the company   Drive continuous improvement programs to lower testing costs, reduce turnaround times, and provide a more valued product for internal and external customers      Additional Duties and Responsibilities :

• Routinely review the GAP analysis resulted from internal audit and address compliances with appropriate team members  Investigating customer complaints  Member of site development group with primary responsibility for quality  recommendations regarding laboratory and factory and equipment design  Support and participate in the Company’s project teams and assist with project  scheduling to assure that timelines and deadlines are met efficiently and economically  Develop and conduct appropriate cGMP 21 CFR part 111 training and compliance for all  levels of personnel involved in the manufacturing and release of raw materials and final product  Provide leadership on Food Defense teams  Other duties and projects as assigned  Perform duties for the first year of :   Sanitation Supervisor  Quality Specialist – Batch Records   Quality Specialist – Document Control    SUPERVISORY / BUDGET  Direct reports include Quality department staff   REQUIREMENTS   Education / Experience :   BA / BS in a scientific discipline or equivalent education / experience; graduate degree preferred  Six years’ progressive experience in Quality in food, beverage, dietary supplement, or other regulated industry  Two years’ supervisory experience in a manufacturing setting or equivalent  Quality training and certification preferred  Project management experience preferred    Knowledge / Abilities / Skills :   Strong knowledge of cGMPs in a regulated industry  Strong knowledge of regulatory requirements for the manufacturing of food, beverage, dietary supplements, or Over-the-Counter (OTC) drugs, dietary supplements (21 CFR part 111) preferred.  Strong current knowledge of Quality Control and Assurance methodologies  Demonstrated ability to manage and develop staff  Knowledge of continuous improvement methodology preferred  Able to collaborate, influence and work effectively across multiple departments and locations  Able to independently solve problems and make decisions based on company and / or quality policy  Ability to read, interpret and apply quality standards, SOP’s, specifications and work instructions  Strong data gathering, metrics development, and report generation skills  Strong analytical and problem-solving skills  Strong organization and detail skills  Strong verbal and written communication skills  Strong interpersonal skills  Commitment to and ability to demonstrate TM’s Company values : humility, respect, quality, collaboration, innovation and sustainability    Technical Skills :     Intermediate MS Office skills  Strong Quality Management System knowledge and skills  Experience with Quality and Manufacturing software platforms preferred (i.e.

RedZone, Master Control Qx and Mx modules)  ERP systems preferred    Travel Requirements :

Approximately 10% thereafter which may include international travel    Work Environment :