Director of Quality


Franklin, TN


Job Overview:

The Director of Quality is responsible for overseeing and guiding the development and implementation of the quality programs ensuring the quality of our product and its proper regulatory compliance.

Main Duties and Responsibilities:

Develop policy and maintain the Quality System for multiple sites for manufacture, packaging, warehouse and distribution operations;

  • Ensure adherence to all cGMP policies and company standards;
  • Maintain quality through internal and external inspection of raw materials and finished items purchased, as well as production operations and processes;
  • Direct regulatory affairs and compliance for company;
  • Provide technical guidance and communications to other functional departments, business partners and regulatory agencies as required;
  • Prepare and/or review documentation required for regulatory submissions;
  • Prepare and/or review documentation for all new formulas and master records;
  • Actively lead initiatives toward continuous improvement, training, mentoring and/or coaching of staff in the quality organization;
  • Oversee Quality Assurance and Quality Control teams;
  • Recruit, manage, develop and assess performance of directly reporting staff;
  • Train all employees in respect to quality issues;
  • Follow and enforce cGMP guidelines and processes as established in department SOPs;
  • Perform other duties as deemed necessary

Requirements and Skills:

  • Bachelor of Science in science, business or related field;
  • 5+ year’s equivalent experience;
  • Strong knowledge of FDA and cGMP regulatory guidelines and applications;
  • Knowledge of Part 111 of FDA Code of federal regulations;
  • Excellent written and verbal communications skills;
  • Good organizational skills with great attention to detail;
  • PC literate with intermediate knowledge of applicable software applications.

Work Conditions and Physical Requirements:

  • Ability to sit and stand for extended hours;
  • Ability to view a computer screen and type for extended hours;
  • Ability to lift up to 15 lbs.;
  • Ability to wear any required PPE such as scrubs, hair net, lab coat, and facemask;
  • Must be able to work around a variation of different smells and aromas; TAHR.507F 1.0
  • Other physical requirements include bi-lateral hand and wrist movement and occasional squatting, bending, and twisting;
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