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.