Supply Chain Quality Manager

OpenLoop

. Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors .

Posted 10/6/2026full-timeDallas • Texas • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier qualification, audit management, and compliance with FDA and USP standards. Proven ability to manage CAPA processes and maintain high-quality vendor relationships within pharmaceutical and regulated environments.

Highest-signal resume keywords

Supplier Qualification ManagementFDA 503A/503B RegulationsCAPA Process ManagementSupplier AuditingQuality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Root Cause AnalysisRisk-Tiered QualificationQuality Metrics EvaluationDocumentation ReviewCorrective Action PlansAudit Report PreparationCompliance with USP StandardsPerformance EvaluationQuality Management SystemsStructured Audits

Soft Skills

Detail-OrientedCross-Functional CollaborationEffective Communication

Tools & Technologies

NetSuiteRampComplianceQuestERP PlatformsQMS Platforms

Certifications & Qualifications

ASQ Certified Quality Auditor (CQA)Certified Supplier Quality Professional (CSQP)

Industry Keywords

Pharmaceutical Quality AssuranceCGMP PrinciplesAPI SourcingCompounding StandardsVendor Quality Assurance

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors
Conduct on-site and remote audits, documentation reviews, and risk-tiered qualification
Own the Approved Vendor List (AVL) process
Manage FDA facility registration, CoA traceability, USP monograph compliance, and periodic requalification checks
Conduct supplier scorecards and performance evaluations covering quality metrics, delivery reliability, non-conformance rates, and corrective action responsiveness
Manage CAPA processes for supplier-related quality deviations
Track root cause analysis and verify corrective-action effectiveness
Ensure supplier and incoming material compliance with applicable state board and USP standards, including USP <795>, <797>, <800>, and <1079>
Partner with procurement and compliance teams to maintain audit-ready documentation
Support regulatory inspections and drive continuous improvement in vendor quality standards
Build the supply chain quality process and a best-in-class quality management system
Perform other duties as assigned

Requirements

What you’ll need

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, including CoAs, qualification files, and audit reports
Ability to work 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 and managing vendor qualification/re-qualification processes
Experience with 503A or 503B compounding pharmacies, multi-state/multi-site pharmacy networks, and/or FDA-regulated manufacturing preferred
ASQ Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), or equivalent certification preferred
Familiarity with API and packaging component sourcing, CoA review, FEI/facility registration verification, and distributor vs. manufacturer qualification preferred
Hands-on experience with NetSuite, Ramp, ComplianceQuest, or similar ERP/spend management/QMS platforms preferred
Experience navigating state board of pharmacy requirements preferred
Background building or scaling a supplier quality function preferred
Ability and willingness to work in-office on required days at the Dallas, TX office
Visa sponsorship may be required now or in the future, as addressed in the application form

Benefits

Comp & perks

Medical, Dental, and Vision plans
Flexible Spending/Health Savings Accounts
Flexible PTO
401(k) + Company Match
Life Insurance
Pet insurance
Flat organizational structure
Autonomy, competence, and belonging-focused company culture