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OpenLoop is a telehealth platform that powers virtual care delivery solutions at scale across all 50 US states. The company is building out its supply chain quality function from the ground up, and this role is responsible for establishing a best-in-class quality management system.
You will lead the end-to-end supplier quality program, including qualification of APIs, excipients, and packaging vendors through on-site and remote audits, documentation review, and risk-tiered criteria. You own the Approved Vendor List (AVL) process, managing hard-gate compliance checks such as FDA facility registration, Certificate of Analysis (CoA) traceability, and USP monograph compliance, plus periodic requalification cycles.
Key responsibilities include conducting supplier scorecards and performance evaluations across quality metrics, delivery reliability, non-conformance rates, and corrective action responsiveness. You will manage CAPA (Corrective and Preventive Action) processes for supplier-related quality deviations, including root cause analysis and effectiveness verification. You ensure supplier and incoming material compliance with state board and USP standards (USP <795>, <797>, <800>, <1079>) across multi-state pharmacy operations. You partner with procurement and compliance teams to maintain audit-ready documentation, support regulatory inspections, and drive continuous improvement in vendor quality standards.
OpenLoop operates with a flat organizational structure that emphasizes autonomy, competence, and belonging. The role offers the opportunity to build a supplier quality function from scratch rather than operate within an established one.
REQUIREMENTS:
- Bachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or related field (or equivalent practical experience)
- 4+ years of experience in supply chain quality, vendor quality assurance, or supplier auditing, ideally in pharmaceutical, compounding, or regulated manufacturing environments
- Deep familiarity with FDA 503A/503B regulations, USP compounding standards, and cGMP principles as they apply to suppliers and incoming materials
- Skilled at running structured audits and translating findings into actionable corrective action plans
- Detail-oriented with ability to own documentation-heavy processes (CoAs, qualification files, audit reports) that withstand regulatory scrutiny
- Collaborative operator who works cross-functionally with procurement, compliance, and operations
- Proven track record managing CAPA processes, including root cause analysis and effectiveness verification
- Demonstrated experience conducting supplier audits (on-site or remote) and managing vendor qualification/requalification processes
PREFERRED QUALIFICATIONS:
- Experience with 503A or 503B compounding pharmacies across multi-state/multi-site networks (Texas, Alabama, California a plus) and/or FDA-regulated manufacturing
- ASQ Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), or equivalent certification
- Familiarity with API and packaging component sourcing, including CoA review, FEI/facility registration verification, and distributor vs. manufacturer qualification
- Hands-on experience with NetSuite, Ramp, ComplianceQuest, or similar ERP/spend management/QMS platforms
- Experience navigating state board of pharmacy requirements related to supplier compliance
- Background building or scaling a supplier quality function from the ground up
