Strategic Supplier Quality Manager (FDA/USP)

OpenLoop; Dallas (TX); Presencial; USD 100 000 - 140 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental, Vision

FSA/HSA

Flexible PTO

401k match

Life Insurance

Pet Insurance

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Supply chain quality

Vendor QA

Supplier auditing

Audit execution

CAPA management

Documentation

Cross-functional collaboration

FDA 503A/503B knowledge

cGMP knowledge

Formação académica

Bachelor's degree in related field

Ferramentas

NetSuite

Ramp

ComplianceQuest

Descrição da oferta de emprego

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.