Quality Manager

SUMMARY

The Quality Manager manages the daily operations of the site 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 21 CFR Part 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.

• 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 valued product for internal and external customer

• Routinely review the gap analysis resulted from internal audits 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
  • Lab Tech - Sampler

• Direct reports include Quality department staff
• No direct departmental budgetary oversight

• 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
• New plant and/or production line startup 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…