Director of Quality

Job Description

Job Description

Position Summary:

Reporting into the Chief Executive Officer, the Director of Quality is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products.

Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance 21 CFR Part 111 and 117. Provides leadership and development to assigned teams and staff.

Key Accountabilities

· Establishes, implements, and manages the overall regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all company products. This includes monitoring the complete manufacturing and QA/QC process to ensure conformance and compliance, as well as management of the Quality System, ensuring compliance with applicable local and federal regulatory requirements and/or programs including but not limited to the regulatory requirements of the U.S.

· Provides sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.

· Continuously identifies opportunities to improve the Quality System, product quality, simplify processes and/or reduce of the costs of quality.

· Manages the quality and regulatory staff and departmental resource needs.

· Provides leadership and management to ensure that the mission and core values of the company are put into place.

· Creates and leads a high-performing, innovative, management team that attracts, recruits, develops, and retains exceptional staff.

Competencies

· People Manager competencies: Building talent, Driving for results, Customer focus, Driving for innovation, Emotional intelligence.

· Strategic thinking

· Leadership, coaching, and mentoring

· Communication and influence

· Business acumen

· Financial management

· Technical Capacity

· Analysis and problem solving

Education, Experience, Skills, and Knowledge

· Bachelor’s degree in life sciences or related field required, advanced degree or certification in Quality or Regulatory preferred.

· 10 plus years of experience in the Nutraceutical industry, including management experience required.

· Quality, regulatory anddietary and supplement industry experience required, with extensive knowledge of strategic planning of the USA and worldwide regulations, quality and regulatory processes, and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required.

· Excellent knowledge of Quality Systems Regulations, cGMP, and 21 CFR Part 11, 111, and 117 regulations as they apply to nutraceutical manufacturing required.

· Extensive experience interfacing with FDA and/or regulatory auditors required.

· Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required.

· Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required.

· Track record of success at building and leading high-performing, complex teams.

Work Environment:

· The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

· While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risks of electrical shock.

· The noise level in the work environment is usually moderate.

· While in the plant, the employee must utilize the required personal protective equipment.

Physical Demands:

· 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.

· Physical demands require sitting for extended periods, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.