Head of US Quality Assurance

This role is allocated 80% to Commercial QA for a U.S.-based dietary supplement trading company that sources innovative ingredients and finished goods (OEM) from a global network of third‑party manufacturers, and 20% to serving as the quality communication liaison with a Joint Venture (JV) manufacturing site based in Arizona, USA. Lead commercial quality assurance activities that directly support North American Customer base—ensuring that all traded ingredients and OEM products meet stringent specifications, cGMP, regulatory requirements (FDA 21 CFR Part 111, 117, FSVP), and Customer expectations. Build and manage supplier qualification programs, oversee product release documentation, and provide proactive quality support to customers. Oversee internal and external quality auditing programs. In the JV capacity, act as the primary contact for quality process alignment, facilitating communication between the trading company and the JV on‑site Production and Quality Teams on specifications, change control, and compliance without assuming day‑to‑day manufacturing oversight. Reporting to the Sr. Director of Global Quality, supervise and train U.S.‑based Quality personnel, coordinate with the Global Quality team, and drive a commercial‑focused quality culture that balances compliance with business agility. Essential Functions Commercial QA – Trading Company (80%) Supplier & Supply Chain Assurance –Maintain Foreign Supplier Verification Programs (FSVP) in compliance with FDA requirements. Key Client Service – Serve as the quality point of contact for North American B2B Customers. Provide Quality documentation (CoAs, technical dossiers, audit reports), address Customer quality inquiries, coordinate Supplier Qualification requests, and support Sales, Business Development and Operations Teams with technical expertise to enable business growth. Product Lifecycle & Release – Oversee the quality review and release of all traded ingredients and finished goods based on documentation, including certificates of analysis, batch records, and stability data. Ensure products meet customer specifications and regulatory standards. Identify and monitor quality efficiency and productivity metrics and implement continuous improvement practices where applicable. Change Control & Documentation – Lead change control processes for specifications, SOPs, and supplier changes. Write, edit, and implement controlled documents (SOPs, specifications, qualification protocols). Audit & Compliance – Lead internal and external audits, including hosting FDA or customer audits. Conduct or coordinate third‑party supplier audits to verify cGMP compliance. Lead mock recall programs and processes. Customer Complaints & Adverse Events – Manage investigation, trending, and reporting of customer complaints and adverse events. Implement corrective actions in partnership with suppliers. Facilitate CAPA response to customers. Metrics & Continuous Improvement – Define and monitor quality KPIs (e.g., supplier performance, complaint trends, release turnaround). Use root cause analysis and process mapping to drive improvement across the supply chain. JV Manufacturing Site Communication (20%) Primary Quality Contact Window – Serve as the designated quality communication link between the trading company and the JV manufacturing site, ensuring clear and timely exchange of quality‑related information. Quality Process Alignment – Facilitate alignment on specifications, sampling plans, testing methods, and documentation requirements between the trading company and the JV. Ensure adhereance to the current Quality Agreements. Batch Disposition Support – Collaborate with the JV’s quality team to confirm that batches produced meet agreed specifications before release into the trading company’s supply chain. Issue Escalation – Escalate quality incidents or compliance concerns from the JV to senior management and coordinate resolution activities without assuming direct manufacturing quality management. Additional Job Functions Plan and execute quality projects in accordance with company and business objectives. Investigate and resolve quality issues of strategic importance, particularly those affecting key clients. Assist with the review and compilation of regulatory submissions and technical dossiers. Perform other duties as assigned. Qualifications / Knowledge, Skills, & Abilities Education & Experience Bachelor’s degree in life sciences, chemistry, food science, or related field strongly preferred. Minimum 12 years of experience in quality assurance within the dietary supplement, food, or OTC industry, with substantial experience in commercial QA, supplier management, and client‑facing roles within a trading, distribution, or contract manufacturing environment. Minimum 5 years of leadership experience, including direct supervision of quality staff. Minimum 2 years of external auditing experience. PCQI certification (human and animal foods) and FSVP training required. Quality auditing certification (e.g., ASQ CQA) strongly preferred. Deep expertise in FDA 21 CFR Part 111 (Dietary Supplement cGMPs), Part 117 , and FSVP . Proven ability to manage quality for innovative ingredients and OEM finished goods sourced from third parties. Strong client service orientation—able to communicate complex quality information clearly to internal and external stakeholders. Familiarity with global cGMP guidelines (TGA PIC/s, UK GDP) is a plus. Proficient in ERP systems and document management systems. Soft Skills & Attributes Hands‑on leader comfortable balancing strategic vision with the tactical demands of commercial QA and client support. Exceptional decision‑making skills – identifies issues, evaluates data from multiple sources, and chooses effective courses of action consistent with facts and business constraints. Strong relationship management – able to build trust with key clients, suppliers, and JV partners. Excellent written and oral communication – proficiency in English; skilled at bridging commercial and technical perspectives. Highly organized – establishes clear courses of action for self and others to ensure efficient completion of work. #J-18808-Ljbffr TSI Group