Manager, GMP Supplier Quality Management

Scorpion Therapeutics; Chapel Hill (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k/ESPP

Paid time off

Parental leave

Disability benefits

Job summary

Scorpion Therapeutics is seeking a Senior Supplier Quality professional to establish and maintain the supplier quality program. You will oversee onboarding through performance monitoring of suppliers, CMOs, labs, distributors, and service providers, serving as the primary quality liaison across internal teams.

The role requires deep regulatory knowledge (cGMP, FDA QMSR, ISO standards), strong communication, and leadership to drive continuous improvement in supplier performance and compliance.

Qualifications

• 8+ years QA experience with a Bachelor’s degree (or 6+ with Master’s; 2+ with PhD/ PharmD).
• Vendor oversight experience across suppliers, CMOs, distributors and service providers.
• Strong regulatory knowledge (cGMP; 21 CFR; FDA QMSR; ISO 13485/14971).
• Excellent written and verbal communication skills.
• Experience with audits, risk management, and CAPA.

Responsibilities

• Manage Supplier Quality Management program aligned with FDA QMSR and 21 CFR Part 4.
• Execute risk-based supplier qualification, approval, requalification, and disqualification with GMP auditing.
• Perform GxP Vendor List risk assessments for annual audit scheduling.
• Negotiate and maintain vendor quality agreements and change control docs.
• Develop vendor KPIs/scorecards; monitor performance via metrics and reviews.
• Support investigations and CAPA for deviations/OOS events.
• Coordinate vendor change notifications and assess impact on product quality.
• Escalate vendor quality issues and support regulatory inspections.
• Drive continuous improvement to reduce quality events and improve Right First-Time.
• Maintain vendor-management records and train staff on vendor quality procedures.

Skills

Vendor oversight

Quality assurance

Regulatory knowledge

Cross-functional leadership

GxP knowledge

Education

Bachelor’s degree

Master’s degree

Tools

MS Office

DocuSign

QMS software

Job description

Who You Are

This role is responsible for establishing, maintaining, and continuously improving the Supplier Quality program for all United Therapeutics sites. Own quality oversight of assigned suppliers from onboarding through ongoing performance monitoring to disengagement; serve as primary quality contact for internal stakeholders.

Responsibilities:

• Manage Supplier Quality Management program aligned with FDA QMSR and 21 CFR Part 4.
• Execute risk-based supplier qualification, approval, requalification, and disqualification (suppliers, contract manufacturers/labs, distributors, service providers, critical material vendors) with GMP Auditing.
• Perform GxP Vendor List risk assessments to build the annual vendor audit schedule.
• Negotiate and maintain supplier Technical/Quality Agreements (quality, compliance, notification, change control, documentation).
• Develop vendor KPIs/scorecards; monitor performance via metrics, trends, management review inputs, and escalation.
• Support investigations and CAPA for deviations/nonconformance, OOS events.
• Coordinate vendor change notifications; assess impacts to product quality, regulatory filings, validated processes, specs, labeling, and supply continuity.
• Escalate vendor quality issues (material holds, corrective actions, field impact, recall/regulatory inspection support).
• Drive continuous improvement to reduce quality events and improve Right First-Time (RFT).
• Maintain vendor-management records; author/revise vendor quality procedures and training.

Minimum Requirements:

• 8+ years QA with a Bachelor’s (or 6+ with Master’s, or 2+ with PhD/PharmD)
• 5+ years vendor oversight; 2+ years people management
• Strong technical/regulatory knowledge (cGMP; 21 CFR 210/211; FDA QMSR; ISO 13485; ISO 14971; EU MDR; ICH)
• Experience with supplier qualification, risk management, quality agreements, audits, performance monitoring
• Excellent written/verbal communication.

Preferred Qualifications:

• ASQ Certified Quality Auditor and/or CQM
• MS Office, DocuSign, electronic QMS; AI applications knowledge
• Strong organization, cross-functional leadership/influence, attention to detail.

Benefits (as stated):

• medical/dental/vision/prescription coverage, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits and more.