Lead, Supply Chain Quality & Compliance

Alt; Dallas (TX); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) + Company Match

Flexible PTO

Life Insurance

Pet insurance

Job summary

OpenLoop is transforming telehealth by building a best-in-class quality management system for supplying APIs, excipients, and packaging components. This role focuses on leading supplier qualification, audits, and AVL governance to ensure regulatory compliance across multi-state operations.

You will drive CAPA and supplier performance evaluations, while partnering with procurement and compliance teams to maintain audit-ready documentation and support inspections.

Qualifications

• Bachelor's degree or equivalent in a related field or equivalent practical experience.
• Deep knowledge of FDA 503A/503B, USP standards, and cGMP as they apply to suppliers and incoming materials.
• Experience running structured audits and turning findings into corrective actions.
• Proven track record in CAPA processes and root-cause analysis.
• Experience conducting supplier audits (on-site or remote) and managing qualification programs.

Responsibilities

• Lead supplier qualification and audits across API, excipient, and packaging vendors, including on-site and remote audits.
• Own the Approved Vendor List (AVL) process and qualification cycles, including regulatory checks.
• Conduct supplier scorecards and evaluate quality metrics and corrective actions.
• Manage CAPA processes for supplier quality deviations and verify effectiveness.
• Ensure compliance with state board and USP standards across multi-state pharmacy operations.
• Collaborate with procurement and compliance to maintain audit-ready documentation and support inspections.
• Other duties as assigned.

Skills

Audit planning

CAPA management

Regulatory knowledge

Supplier qualification

Cross-functional collaboration

Documentation management

Education

Bachelor's degree or equivalent

Tools

NetSuite

Ramp

ComplianceQuest

Job description

OpenLoop is transforming telehealth by building a best-in-class quality management system for supplying APIs, excipients, and packaging components. This role focuses on leading supplier qualification, audits, and AVL governance to ensure regulatory compliance across multi-state operations.

You will drive CAPA and supplier performance evaluations, while partnering with procurement and compliance teams to maintain audit-ready documentation and support inspections.