Supply Chain Quality Manager

OpenLoop Health•Dallas, TX

About The Position

OpenLoop'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.

Requirements

Bachelor'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 environments
Deep familiarity and working knowledge of 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 clear, actionable corrective action plans
Detail-oriented and comfortable owning documentation-heavy processes (CoAs, qualification files, audit reports) that need to hold up under regulatory scrutiny
A collaborative operator who can work cross-functionally with procurement, compliance, and operations without slowing down the business
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/re-qualification processes

Nice To Haves

Certified or working toward certification (ASQ CQA, CSQP, or equivalent) is a plus, but hands-on audit experience matters more than the credential
Experience working with 503A or 503B compounding pharmacies, across multi-state/multi-site pharmacy 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, or ComplianceQuest (or similar ERP/spend management/QMS platforms) for supplier and quality data tracking
Experience navigating state board of pharmacy requirements as they relate to supplier compliance
Background in building or scaling a supplier quality function from the ground up, rather than just operating within an established one

Responsibilities

Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors, including on-site and remote audits, documentation review, and risk-tiered qualification criteria
Own the Approved Vendor List (AVL) process, managing hard-gate compliance checks (FDA facility registration, CoA traceability, USP monograph compliance) and periodic requalification cycles
Conduct supplier scorecards and performance evaluations covering quality metrics, delivery reliability, non-conformance rates, and corrective action responsiveness
Manage CAPA (Corrective and Preventive Action) processes for supplier-related quality deviations, tracking root cause analysis and verification of effectiveness
Ensure supplier and incoming material compliance with applicable state board and USP standards (e.g., USP <795>, <797>, <800>, <1079>) across multi-state pharmacy operations
Partner with procurement and compliance teams to maintain audit-ready documentation, support regulatory inspections, and drive continuous improvement in vendor quality standards
Other duties as assigned.