Director of Quality Profile / Job Description

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.

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;
• Oversee Environmental Health and Safety Specialist (EHS);
• 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

• 10+ years of progressive leadership experience with at least 5 years within quality
• Bachelor’s degree in engineering or manufacturing, Masters preferred
• Practical understanding of Quality Systems (i.e. ISO 9000, TL9000) and certification process for UL, CE
• Experience managing and implementing quality process creation and control
• Experience managing field quality performance including voice of the customer, field data, partnering with engineering to prioritize work focused on product reliability
• Demonstrated experience in building a culture of quality
• Proven success in resolving quality, compliance, supply and safety risks
• Ability to work cross functionally and strategically with leaders across the business
• Strong interpersonal and talent management skills