Senior Supply Chain Quality Manager: Pharma Audits & CAPAs

Alt; Dallas (TX); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Flexible PTO

401(k) + company match

Life insurance & pet insurance

Job summary

OpenLoop Health is seeking a qualified professional to build and manage a centralized supplier quality function for pharmaceutical supply chains. You will lead audits, qualify vendors, maintain the AVL, and drive CAPA processes with regulatory compliance across multi-state pharmacy operations.

The role emphasizes cross-functional teamwork with procurement and compliance, plus ongoing documentation and audit readiness to support regulatory inspections.

Qualifications

• Bachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or a related field, or equivalent experience.

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 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.

Skills

Quality management

Auditing

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in supply chain, quality assurance, or pharmaceutical sciences

Tools

NetSuite

Ramp

ComplianceQuest

Job description

OpenLoop Health is seeking a qualified professional to build and manage a centralized supplier quality function for pharmaceutical supply chains. You will lead audits, qualify vendors, maintain the AVL, and drive CAPA processes with regulatory compliance across multi-state pharmacy operations.

The role emphasizes cross-functional teamwork with procurement and compliance, plus ongoing documentation and audit readiness to support regulatory inspections.