Supply Chain Quality Manager

OpenLoop; Dallas (TX); Sur place; USD 100 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

FSA/HSA

Flexible PTO

401k match

Life Insurance

Pet Insurance

Résumé du poste

OpenLoop in Dallas seeks a Senior Supplier Quality Engineer to build and lead the quality system for supplier management in a regulated pharmaceutical setting.

You will lead audits, manage the Approved Vendor List, and drive CAPA programs across API, excipient, and packaging suppliers, ensuring compliance with FDA, USP, and state board requirements while collaborating with procurement and operations to sustain audit-ready documentation.

Qualifications

• Bachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or related field.
• 4+ years of experience in supply chain quality, vendor quality assurance, or supplier auditing in regulated environments.
• Deep knowledge of FDA 503A/503B regulations, USP compounding standards, and cGMP for suppliers and incoming materials.
• Ability to run structured audits and translate findings into corrective action plans.
• Detail-oriented with documentation-heavy processes (CoAs, audit reports) under regulatory scrutiny.
• Collaborative with procurement, compliance, and operations to maintain compliance.

Responsabilités

• 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 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.

Connaissances

Supply chain quality

Vendor QA

Supplier auditing

Audit execution

CAPA management

Documentation

Cross-functional collaboration

FDA 503A/503B knowledge

cGMP knowledge

Formation

Bachelor's degree in related field

Outils

NetSuite

Ramp

ComplianceQuest

Description du poste

About OpenLoop

OpenLoop 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 OpenLoop

OpenLoop 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 Role

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.

What You'll Do

• 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 , , , ) 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.

Who You Are

• 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
• Certified or working toward certification (ASQ CQA, CSQP, or equivalent) is a plus, but hands-on audit experience matters more than the credential
• 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

Preferred Qualifications

• 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

Our Benefits

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

Our Company

We 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.