Traditional Medicinals
Quality Manager
Quality - Rocky Mount, VA - Full Time
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
REQUIREMENTS
Education/Experience:
Physical/Mental Requirements:
We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
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
- 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
- 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
- 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
- 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
- Ability to travel up to 50% for first four months. Approximately 10% thereafter which may include international travel
- Climate-controlled fast paced production environment working across all areas of production including, IMA, blending, Mezzanine, case packing, display area, planning, logistics, Quality Control, Quality Assurance.
Physical/Mental Requirements:
- An employee must meet the physical demands described here to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand, walk, reach with hands and arms, and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision.
- This position is based in Rocky Mount, VA and is onsite Monday through Friday supporting a three-shift operation.
- Remote candidates will not be considered for this role.
We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
