2 часа назад
Supplier Quality Manager (Pharmaceutical Supply Chain)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supplier Quality Manager (Pharmaceutical Supply Chain): Building a best-in-class supplier quality management system for multi-state telehealth pharmacy operations with an accent on vendor qualification, audits, regulatory compliance, and incoming material quality. Focus on managing CAPA investigations, verifying FDA and USP requirements, and scaling supplier quality processes across API, excipient, and packaging vendors.
Location: Hybrid, Dallas, Texas, United States
Company
provides telehealth support solutions that help companies deliver virtual care across multiple specialties and all 50 states.
What you will do
- Build and manage a supplier quality management system and centralize quality supply chain functions.
- Lead supplier qualification and ongoing on-site and remote audit programs for API, excipient, and packaging vendors.
- Own the Approved Vendor List process, including FDA facility registration, CoA traceability, USP monograph compliance, and periodic requalification.
- Evaluate supplier performance through scorecards covering quality, delivery reliability, non-conformances, and corrective action responsiveness.
- Manage supplier-related CAPA processes, including root cause analysis and effectiveness verification.
- Partner with procurement and compliance teams to maintain audit-ready documentation and support regulatory inspections.
Requirements
- 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 in pharmaceutical, compounding, or regulated manufacturing environments.
- Working knowledge of FDA 503A/503B regulations, USP compounding standards, and cGMP principles.
- Experience conducting supplier audits and managing vendor qualification and requalification processes.
- Ability to translate audit findings into corrective action plans and manage documentation such as CoAs, qualification files, and audit reports.
- Ability to collaborate with procurement, compliance, and operations teams.
Nice to have
- Experience with 503A or 503B compounding pharmacies, multi-state or multi-site pharmacy networks, or FDA-regulated manufacturing.
- ASQ Certified Quality Auditor, Certified Supplier Quality Professional, or equivalent certification.
- Experience with API and packaging component sourcing, CoA review, FEI or facility registration verification, and distributor versus manufacturer qualification.
- Experience with NetSuite, Ramp, ComplianceQuest, or similar ERP, spend management, or QMS platforms.
- Experience building or scaling a supplier quality function from the ground up.
Culture & Benefits
- Flat organizational structure with autonomy to contribute ideas and drive improvements.
- Medical, dental, and vision plans.
- Flexible Spending Accounts and Health Savings Accounts.
- Flexible paid time off, 401(k) with company match, life insurance, and pet insurance.
- Culture centered on autonomy, competence, and belonging.
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