Supply Chain Quality Manager

OpenLoopOpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring care anywhere. Our telehealth support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states.About the RoleOpenLoop's mission is to bring care anywhere by powering telehealth solutions at scale. The goal of this team is to build the supply chain quality process from the ground up and centralize all quality supply chain functions to one team. The goal of this role is to build a best in class quality management system.What You'll DoLead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors, including on-site and remote audits, documentation review, and risk-tiered qualification criteriaOwn the Approved Vendor List (AVL) process, managing hard-gate compliance checks (FDA facility registration, CoA traceability, USP monograph compliance) and periodic requalification cyclesConduct supplier scorecards and performance evaluations covering quality metrics, delivery reliability, non-conformance rates, and corrective action responsivenessManage CAPA (Corrective and Preventive Action) processes for supplier-related quality deviations, tracking root cause analysis and verification of effectivenessEnsure supplier and incoming material compliance with applicable state board and USP standards (e.g., USP <795> , <797> , <800> , <1079>) across multi-state pharmacy operationsPartner with procurement and compliance teams to maintain audit-ready documentation, support regulatory inspections, and drive continuous improvement in vendor quality standardsOther duties as assigned.Who You AreBachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or a related field (or equivalent practical experience)4+ years of experience in supply chain quality, vendor quality assurance, or supplier auditing, ideally within pharmaceutical, compounding, or regulated manufacturing environmentsDeep familiarity and working knowledge of FDA 503A/503B regulations, USP compounding standards, and cGMP principles as they apply to suppliers and incoming materialsSkilled at running structured audits and translating findings into clear, actionable corrective action plansDetail-oriented and comfortable owning documentation-heavy processes (CoAs, qualification files, audit reports) that need to hold up under regulatory scrutinyA collaborative operator who can work cross-functionally with procurement, compliance, and operations without slowing down the businessCertified or working toward certification (ASQ CQA, CSQP, or equivalent) is a plus, but hands-on audit experience matters more than the credentialProven track record managing CAPA processes, including root cause analysis and effectiveness verificationDemonstrated experience conducting supplier audits (on-site or remote) and managing vendor qualification/re-qualification processesPreferred QualificationsExperience working with 503A or 503B compounding pharmacies, across multi-state/multi-site pharmacy networks (Texas, Alabama, California a plus), and/or FDA-regulated manufacturingASQ Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), or equivalent certificationFamiliarity with API and packaging component sourcing, including CoA review, FEI/facility registration verification, and distributor vs. manufacturer qualificationHands-on experience with NetSuite, Ramp, or ComplianceQuest (or similar ERP/spend management/QMS platforms) for supplier and quality data trackingExperience navigating state board of pharmacy requirements as they relate to supplier complianceBackground in building or scaling a supplier quality function from the ground up, rather than just operating within an established oneOur BenefitsMedical, Dental, and Vision plansFlexible Spending/Health Savings AccountsFlexible PTO401(k) + Company MatchLife Insurance, Pet insurance, and moreOur CompanyWe have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work.Sound like a good fit? We'd love to meet you.