Yogi is seeking a talented and experienced individual to lead the Quality function by developing, implementing, maintaining, and communicating the organization’s quality strategy and programs. This position offers a meaningful opportunity to help refine the Quality Management System while developing and managing the Quality team. Located in Springfield, Oregon, at Yogi we believe the purpose of business is to serve. Our company was founded on that belief and uses service as its guiding principle: “Feel Good, Be Good, Do Good.” We are committed to providing healthy, natural teas that are accessible to as many people as possible. If this aligns with your values and passion, you could be a fit for us and us for you.
The Quality Assurance Director is responsible for the effective management of Yogi Tea’s Quality Programs. This role encompasses hands-on responsibilities in governing the elements of product quality, dietary supplements compliance (21CFR Part 111) and food safety/sanitation (21CFR Part 110 and 117). This position will provide leadership for the development, implementation, communication, and maintenance of quality systems, policies and procedures in accordance with US FDA regulations, Global Food Safety Initiatives, and industry best practices.
Key Areas of Responsibilities:
Leads the Company in meetings with the US FDA, Oregon Department of Agriculture, other regulatory agencies and third party inspections and audits.
Responsible for the effective management and maintenance of manufacturing facility compliance to and with the dietary supplements regulations 21CFR Part 111
Responsible for the effective management and maintenance of Quality Audit program and assessing improvement initiatives resulting from all quality audits, internal and external. Participate in third party compliance audits of suppliers, manufacturers and distributors.
Responsible for the effective management and maintenance of the Company’s sanitation program ensuring compliance to FDA and cGMP practices.
Effective management and maintenance of the documentation and retention processes as it relates to the Quality System and FDA guidelines/regulations
Manage final review and approval of Master Batch Records, Manufacturing Batch Records, SOPs, Change Control Documentation, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Supplier Qualifications.
Oversee development and validation of laboratory test methods
Continuous Improvement and Team Collaboration
Effectively interact with Manufacturing, Procurement and R&D to maintain product supply and help transition new products from the bench, through piloting and into production.
Analyze, evaluate, trend, and present key performance quality indicators and recommendations to executive management on a quarterly and annual basis.
Maintain and continuously improve the company’s quality management system by directing and providing oversight and input into the relevant quality systems and standards including:
Management of Supplier Corrective Action Program (SCAR) and Vendor Risk Management in close collaboration with Procurement
Quality inspection and product release programs for incoming and in-process materials and components and finished goods
Supplier qualification – oversight of the supplier qualification procedures, audit plan and assessments.
Equipment and or material qualification/validation – review and approval of risk assessments, quality testing plans, qualification/validation protocols and reports for manufacturing equipment, systems and processes. Approve related specifications, batch records, etc.
CAPA (Corrective Actions and Preventive Actions) – facilitate investigations and provide oversight and approval for the CAPA system. Perform periodic trending
Leadership and Team Development
Hire, manage, and develop Quality Assurance staff and to support the company’s goals and objectives. Conduct employee performance evaluations; assist in setting goals and objectives in alignment with the overall company goals and objectives
Develop the fiscal QA budget including capital expense and assure the department operates within the agreed upon budget numbers.
Direct, participate in and provide philosophical direction on the “Culture of Quality” for the Company.
Training of all company personnel in the requirements, documentation and maintenance of Quality Systems and cGMP training
Provide leadership on Food Safety, Food Defense and HACCP teams
Other duties as assigned
Applied Quality Systems in a foods, beverages, or dietary supplements manufacturing environment.
In depth knowledge of CFR Title 21 - Part 110 cGMP in Manufacturing, Packing or Holding Human Food
CFR Title 21 – Part 111 cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
CFR Title 21 – Parts 117 cGMP, Hazard Analysis, and Risk-Based Preventative Controls for Human Food (FSMA)
Canadian Natural Health Products Regulations
Working knowledge of Global Food Safety Initiatives (SQF, BRC, IFS, FSSC2200), Hazard Analysis and Critical Control Point Principles and Application Guidelines, Kosher, USDA Organic standards and Non-GMO Standards.
Strategic and conceptual thinking
Analytical thinking, problem solving and solutions oriented
Leading development and implementation of strategic goals, budget/cost control and process
Desire to understand individuals and develop them and their performance
Detail oriented in work performance and documentation
Decision making at stated level of authority
Communicate effectively with all levels of the organization
Ability to translate technical message in layman’s terms
Build trust, relationships and work collaboratively at all levels
Adapt and manage in changing environments
Courage to influence others and hold the line on quality and guidelines
Ability to teach and communicate the “whys” of regulations and guidelines
Skills & Abilities in:
Manage time effectively
Professionalism in behavior and conduct
Ensure collaborative relationships with industry, trade, other association, regulatory agencies and East West Tea Company Staff.
Foster team work in efforts towards continuous improvement
Model ‘best in class’ behaviors with a focus on safety, quality and policy
Proficient in Microsoft Office products
Knowledge and Experience:
B.S. degree or higher in biological sciences, chemistry or a related discipline.
Minimum of 7-10 years of Quality Systems supervisory/management experience within the Dietary Supplement, Food, Drug, Medical or a related regulated industry.
Experience in interacting with regulatory agencies and conducting cGMP or BRC type audits.
Botanical and Supply Chain experience a plus
This position works in an office setting approximately 75% of the time and in laboratory, storage, and production areas the remaining 25% of the time. Production areas can be noisy and/or dusty and require special attention to safety and GMP, and HACCP requirements.