Director Supplier Quality Assurance

The Director of Supplier Quality Assurance is responsible for managing the QA function within the established guidelines and internal standards to ensure the production of the highest quality products in the safest and most efficient manner. Specifically, within this role ensure compliance with FDA regulations mandated in 21 CFR Part 111 and 117 (FSMA).Functions and duties of this role include, but are not limited to:Leads development, implementation, enforcement, and continuous improvement of established policies, strategies, and procedures related to quality systems and food safety to achieve company quality-related goals and objectives.Leads company Quality Assurance co-man group and supplier group to implement corrective actions to reverse negative trends in manufacturing related to consumer complaints. Drives root cause analyses, corrective actions, and continuous improvement activities.Leads cross-functional teams to champion the resolution of key quality issues. Develops (with VP of QA/RA) action plans and recommendations for the Leadership Team on major quality and safety concerns that could lead to business interruption.Leads the investigation, containment, and closure of supplier-related quality complaints, non-conformances, and CAPAs.Develops and maintains quality agreements for suppliers in support of company specifications and standards.Leads the notification, implementation, and proper documentation of change requests, planned deviations, or rework.Provides quality and technical support to Product Development teams in the development and implementation of company products.Statistically analyzes quality data and identifies potential problem areas to prevent issues.Ensures effective risk mitigation management to reduce risk and interruption in supply and co-manufacturing operations.Drives the CAPA management program. Ensures CAPAs are implemented, checked for effectiveness, and closed.Leads departmental staffing and people development strategies to ensure technical competence, creativity, teamwork, and broad business knowledge leading to continued managerial and technical leadership for Quality and Food Safety.Provides the business with supplemental industry expertise through their industry connections/network of subject matter experts and through building strategic partnerships with identified third parties.Supports the department and company Health & Wellbeing QA-RA with other projects as needed.Job RequirementsThe successful candidate will have the following qualifications:A minimum of a bachelor’s degree from an accredited college or university in a related field or equivalent combination of education, training, and experience that provides the required knowledge, skills, and abilities.Master’s degree from an accredited university in a related field or equivalent combination of education, training, and experience that provides the required knowledge, skills, and abilities preferred.12+ years of relevant Quality Assurance experience in the food/supplement industry.Strong understanding of FDA regulations for Foods FDMA (21 CFR part 117) and Dietary Supplements (21 CFR part 111).Working knowledge of plant layout and manufacturing operations to effectively troubleshoot and correct production-related problems and recognize constraints and limitations affecting new product design and implementation.Strong working knowledge of GMPs and FDA/ISO guidelines for manufacturing of food and supplement products.Strong analytical and critical thinking skills.Strong attention to detail with interpersonal and communication skills.Prior experience managing and developing others.Ability to represent the company needs when dealing with suppliers, contract manufacturers, regulatory agencies, and other departments within the corporation.Typical hybrid office environment with flexibility for industry events and up to 40% travel for supplier visits.100% company-paid medical, dental, and vision insurance for employees (PPO, HMO, and Kaiser options).Robust Family Planning benefits.A 401k plan with company match, short and long-term disability coverage.A generous PTO and sick policy that includes 13+ paid annual holidays.An Employee Assistance Program, including membership for guided meditation for all employees.Monthly tech and wellness reimbursement.

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