Quality Assurance Manager

Nulixir, a nano-biotechnology start-up, is a VC-backed business-to-business (B2B) company that develops, manufactures, and licenses intellectual property (IP) for smart nanocarriers, called nanovesicles, which optimize the performance of functional ingredients in food & beverage products. Nulixir, as the Function HouseTM, is revolutionizing the functional ingredient space by introducing a realm of functionality and shaping the future of intelligent food. This patented technology (70+ patents) has applications across multiple verticals in food and beverage (e.g., nootropics, energy stimulants, vitamins, probiotics, protein, etc.). Founded in 2019, the company brought together a team of CPG leaders, cancer researchers, US attorneys, and nutritionists to overcome long-standing challenges in the Food and Beverage Industry. The firm’s founder has extensive experience in the development of nanocarriers for cancer therapeutics. About the Role Nulixir is seeking an experienced, hands-on Quality Manager to lead the Quality function at our Austin manufacturing facility. The Quality Manager will have site-level responsibility for Quality Assurance and Quality Control and will own the execution, maintenance and continuous improvement of Nulixir's Quality Management System. This individual will ensure manufacturing operations comply with applicable FDA, cGMP, food safety, customer and internal quality requirements. This role has direct responsibility for product release and disposition, GMP compliance, raw-material controls, specifications, batch-record review, deviations and CAPAs, OOS/OOT investigations, supplier quality, sanitation and environmental monitoring, document control, training and audit readiness . This is a hands-on Quality leadership position. The successful candidate will maintain a strong presence on the manufacturing floor, independently identify and elevate Quality risks, make sound product-quality decisions, lead investigations and build practical Quality systems that can scale with a rapidly growing manufacturing operation. Key Responsibilities Quality Leadership & QMS Serve as the senior onsite Quality authority for Nulixir's Austin manufacturing operations. Own and continuously improve the site's Quality Management System in accordance with applicable FDA, cGMP, food safety and customer requirements. Lead, train and develop Quality Technicians and other Quality personnel. Establish Quality priorities and ensure appropriate coverage across receiving, manufacturing, testing and finished-product release. Develop, review and approve SOPs, specifications, work instructions, forms and Quality records. Maintain effective document-control, record-retention and Quality training systems. Conduct routine floor inspections and internal audits to ensure established Quality systems are consistently followed. Establish and monitor Quality KPIs and communicate significant risks, CAPA status, audit findings and Quality trends to senior leadership. Manufacturing Quality & Product Release Provide active Quality oversight of batching, manufacturing, filling and packaging operations. Ensure manufacturing activities are performed in accordance with approved batch records, SOPs, specifications and GMP requirements. Oversee line clearance, material verification, label/lot-code verification and applicable in-process Quality controls. Review completed batch records, analytical results and microbiological results for completeness and compliance. Own final Quality review and disposition of finished products. Review and approve finished-product COAs and release documentation. Make or approve documented Release, Hold, Rework or Reject decisions in accordance with established procedures. Ensure products with unresolved Quality concerns remain appropriately controlled and segregated. Nulixir's existing system includes formal finished-product specifications, batch-release checklists, testing records, COA/release documentation and OOS/OOT/Hold disposition controls. Deviations, CAPA & Investigations Own the site's deviation, nonconformance, OOS/OOT and CAPA systems. Lead investigations involving raw materials, manufacturing processes, packaging, microbiological results, sanitation and finished products. Perform and facilitate structured root-cause analysis and risk assessment. Develop effective corrective and preventive actions and drive them through completion. Verify CAPA effectiveness and ensure investigations are appropriately documented and closed. Trend deviations, complaints, OOS/OOT events, supplier issues and audit findings to identify recurring or emerging risks. Lead or support significant customer Quality investigations. Escalate significant product-quality, regulatory or food-safety risks promptly to senior leadership. Raw Materials & Supplier Quality Own Quality approval and release of incoming ingredients and applicable packaging components. Establish and maintain approved raw-material and packaging specifications and acceptance criteria. Ensure supplier COAs are reviewed against approved specifications prior to release. Ensure required identity testing or examination is completed for applicable dietary ingredient lots before use. Oversee material sampling, retain samples, external laboratory submissions and review of test results. Maintain appropriate Quality controls for Quarantined, Released, Hold and Rejected materials. Own Quality aspects of supplier qualification and ongoing supplier monitoring. Lead investigations of nonconforming supplier materials and partner with Supply Chain on supplier corrective actions. Lot-specific dietary-ingredient identity verification before QC release and production use is an established part of Nulixir's incoming-material control system. Food Safety, Microbiology & Environmental Monitoring Oversee Quality testing performed internally and through qualified third-party laboratories. Review laboratory results and lead investigations of abnormal, OOS or OOT findings. Own or oversee environmental monitoring, ATP verification and applicable microbiological monitoring programs. Ensure appropriate sampling plans, frequencies, limits, trending and escalation requirements are established. Provide Quality oversight of sanitation, cleaning verification, GMP hygiene and contamination-prevention programs. Own or support applicable HACCP/HARPC and preventive-control programs. Maintain Quality oversight of allergen, food-safety and Food Defense programs. Regulatory, Audits & Customer Quality Maintain continuous facility readiness for FDA inspections, customer audits and applicable certification audits. Serve as a primary Quality representative during FDA inspections and external audits. Lead Quality-related responses to audit observations and drive corrective actions through closure. Support preparation and execution of regulatory remediation activities where required. Lead completion of customer Quality questionnaires, qualification packages and Quality documentation requests. Serve as a Quality contact for customers, suppliers, laboratories and auditors. Lead or support customer complaints and significant customer Quality investigations. Support supplier audits and qualification activities based on risk. Ensure customer-specific Quality requirements are appropriately incorporated into specifications, procedures and release controls. Training & Quality Culture Develop and maintain GMP and Quality training programs. Ensure personnel are appropriately trained before independently performing GMP-critical activities. Train, coach and develop the Quality team. Provide practical Quality coaching to Production, Warehouse and Operations personnel. Ensure employees understand their responsibility to elevate issues when product safety, quality or compliance may be compromised. Qualifications Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Quality, Engineering or another relevant scientific or technical discipline. 7+ years of progressive Quality Assurance/Quality Control experience in FDA-regulated manufacturing. 3+ years of Quality leadership or management experience , including responsibility for developing and managing Quality personnel. Strong working knowledge of FDA cGMP requirements and Quality systems in regulated manufacturing. Demonstrated experience with batch release, product disposition, deviations, CAPAs, OOS/OOT investigations and change controls. Experience establishing and maintaining raw-material and finished-product specifications. Experience with supplier qualification, COA review and incoming-material controls. Experience with microbiological testing, sanitation verification and/or environmental monitoring. Demonstrated experience preparing for and participating in customer, certification or regulatory audits. Strong root-cause analysis, risk-assessment, technical-writing and problem-solving skills. Demonstrated ability to build and improve Quality systems—not simply administer existing procedures. Strong leadership and communication skills with the ability to work effectively across Quality, Operations, Production and Supply Chain. Ability and willingness to work primarily onsite and maintain a regular presence on the manufacturing floor. Direct experience with 21 CFR Part 111 dietary-supplement cGMP requirements. Experience with food/beverage manufacturing and 21 CFR Part 117 / FSMA requirements. HACCP and/or Preventive Controls Qualified Individual (PCQI) training. Experience with NSF, SQF, BRCGS or comparable GMP/food-safety certification programs. Experience investigating microbiological OOS results and complex product-quality issues. What We're Looking For We are looking for a Quality leader who combines strong technical knowledge with practical manufacturing judgment . This is an opportunity to lead and continue building the Quality organization of a rapidly growing manufacturing company. #J-18808-Ljbffr Nulixir Inc.