Quality Assurance Director

Job Title: Director/Senior Manager of Quality Assurance

At Fungi Perfecti, we are seeking a highly skilled and experienced Director/Senior Manager of Quality Assurance to join our team. This is a full-time, exempt position with business hours Monday – Friday, 8:00 a.m. – 4:30 p.m.; work outside of these days and hours occur occasionally in order to meet the needs of the business.

Job Summary:

The Director/Senior Manager of Quality Assurance is responsible for developing, managing, monitoring and coordinating quality control and quality assurance programs for the Company's dietary supplement manufacturing processes to ensure adherence to cGMP regulations and other applicable federal and state regulatory requirements.

Key Responsibilities:

• Provides leadership in developing and maintaining quality systems and assuring alignment with 21 CFR Part 111 cGMP requirements for the manufacturing, packaging, labeling, and holding of dietary supplements and 21 CFR Part 117 cGMP requirements for hazard analysis and risk-based preventative controls for human food.
• Guides and encourages internal communication on quality issues throughout the organization.
• Independently detects quality problems and implements quality solutions.
• Ensures compliance with cGMP regulations related to dietary supplement identity, purity, strength and composition.
• Establishes, maintains and monitors for the Company and contracted facilities procedures and scientifically sound and appropriate written control for operational and quality system activities, including specifications, master manufacturing records, plans, procedures and documentation of operational and quality system activities. Periodically reviews documentation and performs internal audits to ensure compliance.
• Assures cleaning and sanitation programs for dietary supplement products are implemented, maintained, monitored, and reported according to the GMP requirements.
• Periodically evaluates the quality systems and identifies opportunities for improvement of quality systems and processes.
• Confers with department heads and maintains positive working relationships in order to support compliance activities.
• Implements and assists in 21 CFR Part 111 cGMP training for designated employees.
• Develops and coordinates with manufacturers all regulatory requirements and documentation.
• Provides a controlled process for approval and release of controlled documents. Maintains the document control system ensuring document integrity, security and accessibility.
• Acts as the main point of contact for audits performed by third parties of Company facilities, contract manufacturers, suppliers, and other vendors performing functions associated with the manufacture, packaging, labeling and holding of dietary products for the Company.
• Develops, reviews and approves consumer complaints reports, ensuring all complaints are appropriately investigated by the Company, evaluating the findings, and reporting findings as required.
• Assures all life-threatening, serious and unexpected adverse events or reactions associated with Company dietary supplement products are properly documented, evaluated, and reported.
• Implements, monitors, maintains an inspection system that ensures Company dietary supplement products are produced in compliance with internal procedures, established specifications, and GMP requirements.
• Ensures implementation and maintenance of pest control programs at the Company and works with department leadership to design/revise pest control programs to prevent contamination of products.
• Coordinates the activities surrounding regulatory inspections.
• Initiates, develops with contractor(s), and executes Quality Agreements as necessary to ensure that all quality-related roles and responsibilities between the Company and contracted firms are defined and implemented prior to performing activities associated with the manufacture, packaging, labeling or holding of dietary supplement product(s).
• Assists in identification, development, and execution of processes to reduce the risk of intentional harm to the Company and contracted firms associated with the manufacture, packaging, labeling or holding of dietary supplement product(s).
• Ensures packaging revisions are compliant with applicable regulations and implements check and inspections to ensure that packaging is designed and printed with approved content.
• Participates in the development of product specifications.
• Reviews all marketing, education, print and digital materials intended for consumer or industry distribution to ensure Dietary Supplement Health and Education Act (DSHEA) compliance.
• Supervises assigned staff, hires, evaluates, trains and implements corrective action as necessary.
• Reviews statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.
• Provides training to employees or oversees the deployment of training through department members.
• May serve as the quality representative on cross-functional teams.
• Performs a variety of other administrative duties as assigned.

Requirements:

• Bachelor's Degree in Quality Assurance or Control, Manufacturing Management, or closely related field of study from an accredited institution of higher education. A combination of relevant experience and education may be considered in lieu of a four-year degree.
• Eight (8) years of professional experience in quality assurance/control; five (5) or more years' experience leading quality assurance/control is required.
• Has demonstrated track record of managing hands-on cGMP manufacturing operations
• Experience with analytical methodologies and establishing product specifications
• Preferred experience with NSF, ANSI, and/or SQF
• Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules.
• Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles.
• Solid technical understanding of GMP biologics manufacturing processes and equipment.
• The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
• Exceptional focus on quality and attention to detail.
• Possession of, or ability to obtain a driver's license acceptable for use in the state of Washington.

Knowledge, Skills & Abilities:

• Ability to juggle multiple projects, adjust priorities as needed, and shift gears in a fast-paced business environment.
• Ability to communicate effectively in writing as appropriate for the needs of the audience.
• Ability to communicate at all levels within and outside of the Company while living the Company values.
• Ability to bring others together and reconcile differences.
• Ability to act with high moral standards and integrity.
• Skill in applying complex analytics and conceptual thinking skills to develop and evaluate options and implement solutions.
• Demonstrated ability to perform quality control analytics through tests and inspections of products, services, or processes to evaluate quality or performance.
• Knowledge of business and management principles involved in strategic planning, resource allocation, leadership techniques, production methods, and coordination of people and resources.
• Ability to operate a personal computer in a networked environment; proficient in Microsoft Office suite. Familiarity with statistical software highly preferred.

Physical & Mental Requirements:

• Ability to lift and carry up to 20 pounds on an infrequent basis.
• Ability to sit for prolonged periods of time; a stand-up desk is available upon request.
• Ability to communicate effectively by expressing oneself clearly and accurately in a business conversation.
• Ability to see details at close range (within a few feet of the observer).
• Ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g. patterns of numbers, letters, words, or mathematical operations).
• Ability to perceive, recognize, inspect and assess a variety of work situations in order to analyze and make recommendations.
• Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Ability to concentrate for extended periods of time and apply deductive and inductive reasoning, problem sensitivity and mathematical reasoning.
• Ability to match or detect differences between colors, including shades of color and brightness. Ability to see details at a distance.

Salary Range (DOE): $120,000 – 160,000/yr

For information about our benefits, please go to:

The Company's pay range for this job is published in compliance with the State of Washington 's Equal Pay Opportunities Act and is not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with labor market data, or other applicable law.

The Company is unable to provide assistance to those seeking authorization to work in the US.

Fungi Perfecti, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, genetic information, national origin, disability, or veteran status.

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