Openloophealth

Supply Chain Quality Manager

Dallas, TX - HQ, Remote. Posted a month ago

The role

This person will build a best in class quality management system and a supply chain quality process from the ground up. They will lead supplier qualification, audit programs, and manage CAPA processes for supplier-related quality deviations.

What you will do

  • Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors
  • Own the Approved Vendor List (AVL) process
  • Conduct supplier scorecards and performance evaluations
  • Manage CAPA processes for supplier-related quality deviations
  • Ensure supplier and incoming material compliance with applicable state board and USP standards
  • Partner with procurement and compliance teams to maintain audit-ready documentation
  • Other duties as assigned

Required qualifications

  • 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
  • Skilled at running structured audits and translating findings into clear, actionable corrective action plans
  • Detail-oriented and comfortable owning documentation-heavy processes
  • A collaborative operator who can work cross-functionally
  • 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 have

  • 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)
  • 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

Benefits

  • Medical, Dental, and Vision plans
  • Flexible Spending/Health Savings Accounts
  • Flexible PTO
  • 401(k) + Company Match
  • Life Insurance
  • Pet insurance

About the company

OpenLoop provides telehealth support solutions designed to streamline and simplify go-to-market care delivery for companies offering virtual support to patients across 50 states. The company has a relatively flat organizational structure with core values of Autonomy, Competence and Belonging.

Supply Chain Quality Manager at Openloophealth | JobZoey