Manager, GMP Supplier Quality Management

United Therapeutics Corporation•RTP, NC, NC

About The Position

This role is responsible for establishing, maintaining, and continuously improving the Supplier Quality program for all United Therapeutics sites. It ensures that suppliers, contract manufacturers, contract laboratories, service providers, and other external partners consistently meet company quality standards, regulatory requirements, and business expectations. The manager owns quality oversight of assigned suppliers from onboarding through ongoing performance monitoring to disengagement, ensuring compliance, reliability, and continuous improvement. The role also serves as a primary quality contact for internal stakeholders, supports responsible sites with issue resolution, contributes to supplier strategy, and participates in cross-functional initiatives.

Requirements

Bachelor's degree and 8 or more years of quality assurance experience, or master's degree and 6 or more years of quality assurance experience, or PhD/PharmD and 2 or more years of quality assurance experience.
At least 5 years of vendor oversight experience.
At least 2 years of direct people management or leadership experience.
Strong technical knowledge and operational experience in the pharmaceutical or GMP-regulated industry; ability to interpret technical, quality, regulatory, and manufacturing documentation and translate requirements into practical supplier oversight expectations.
Demonstrated knowledge of applicable regulatory and quality-system requirements, such as cGMP, 21 CFR Parts 210 and 211, FDA QMSR, ISO 13485, ISO 14971, EU Medical Device Regulation, and relevant ICH Guidance.
Experience with supplier qualification, risk management, quality agreements, audits, and performance monitoring.
Sound judgment in quality risk assessment, compliance decision-making, and issue escalation.
Experience supporting regulatory inspections, notified body audits, customer audits, or internal quality audits.
Excellent written and verbal communication skills, including preparing clear quality agreements, executive summaries, procedures, and inspection responses.

Nice To Haves

Certified Quality Auditor (ASQ or another certifying body).
Certified Quality Manager (CQM)-ASQ or another certifying body.
Knowledge of MS Office, DocuSign, and electronic QMS systems.
Knowledge of AI applications in supplier quality management, such as predictive analytics for quality control and automation of routine tasks.
Strong organization skills and ability to manage competing priorities and prioritize workload.
Ability to lead cross-functional teams, influence without direct authority, and communicate effectively with internal stakeholders and external suppliers.
Attention to detail and commitment to seeing tasks through to completion.

Responsibilities

Manage the Supplier Quality Management program in alignment with FDA pharmaceutical and combination product regulations, including FDA QMSR and 21 CFR Part 4 requirements.
Assist with risk-based supplier qualification, approval, requalification, and disqualification for suppliers, contract manufacturers, contract laboratories, distributors, service providers, and critical material vendors; work with business partners and the GMP Auditing team on supplier assessment activities.
Perform GxP Vendor List risk assessments to help develop the annual vendor audit schedule, considering vendor impact, material criticality, supplier performance, regulatory history, quality-system maturity, and business continuity risk.
Negotiate, establish, maintain, and periodically review supplier Technical or Quality Agreements that define quality, compliance, notification, change control, and documentation responsibilities.
Develop vendor Key Performance Indicators and scorecards; monitor quality performance through metrics, trend analysis, management review inputs, and escalation processes.
Participate as a liaison in vendor quality events, including deviations, nonconformance investigations, OOS events, and CAPA implementation, as requested by site Quality or Manufacturing teams.
Manage intake and cross-functional coordination of vendor change notifications, identify impacted sites and locations, and evaluate potential impacts to product quality, regulatory filings, validated processes, specifications, labeling, and supply continuity. Manage change control through implementation or transfer it to responsible business partners as appropriate.
Participate in or initiate vendor quality issue escalation, including material holds, supplier corrective action requests, field impact assessments, recall support, and regulatory inspection support.
Identify supplier quality trends and drive continuous improvement initiatives to reduce quality events, improve Right First-Time performance, and strengthen supplier capabilities.
Ensure vendor-management records are maintained in accordance with company procedures and retention requirements.
Author, revise, and maintain vendor quality procedures, work instructions, templates, and training materials.