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. This role ensures that suppliers, contract manufacturers, contract laboratories, service providers, and other external partners consistently meet company quality standards, regulatory requirements, and business expectations. He/she will own the quality oversight of assigned suppliers from onboarding through ongoing performance monitoring to disengagement ensuring compliance, reliability, and continuous improvement. This individual will also act as the primary quality contact for internal stakeholders, supporting responsible sites with issue resolution, contributing to supplier strategy, and participating in cross-functional initiatives. Manage the Supplier Quality Management program in alignment with FDA pharmaceutical and combination product regulations such as FDA QMSR and 21 CFR Part 4 requirements Assist in the execution of the established risk-based supplier qualification, approval, requalification, and disqualification processes for suppliers, contract manufacturers, contact laboratories, distributors, service providers, and critical material vendors. This includes working closely with key business partners and the GMP Auditing team to collect information and execute supplier assessment activities Perform GxP Vendor List risk assessments to help develop the annual vendor audit schedule considering vendor impact, material criticality, supplier performance, vendor regulatory history, vendor quality system maturity, and business continuity risk Negotiate, establish, maintain and periodically review supplier Technical or Quality Agreements to ensure clear definition of quality, compliance, notification, change control, and documentation responsibilities Develop vendor Key Performance Indicators and Scorecards. Monitor vendor quality performance through metrics, scorecards, trend analysis, management review inputs, and escalation processes Participate as a liaison in vendor quality events such as deviations and nonconformance investigations, OOS events, and CAPA implementation as requested by site Quality teams and/or Manufacturing teams Manage the intake and cross-functional coordination of vendor change notifications including identification of impacted UTC sites and locations and evaluation of potential impact to product quality, regulatory filings, validated processes, specifications, labeling and supply continuity. This may include managing the change control through implementation or transferring the management of changes to responsible business partners Participate in or initiate vendor quality issue escalation, including material holds, supplier corrective action requests, field impact assessments, recall support and regulatory inspection support as required Identify supplier quality trends and drive continuous improvement initiatives to reduce quality events, improve Right First-Time (RFT) performance and strengthen supplier capabilities Ensure vendor-management related records are maintained in accordance with company procedures and retention requirements Author, revise, and maintain vendor quality procedures, work instructions, templates, and training materials

Requirements

8+ years of quality assurance experience with a Bachelor's Degree or 6+ years of quality assurance experience with a Master's Degree or 2+ years of quality assurance experience with a PhD/PharmD
5+ years of vendor oversight experience
2+ years of direct people management or leadership experience
Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry.
Strong 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 judgement 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 the ability to prepare clear quality agreements, executive summaries, procedures, and inspection responses etc.

Nice To Haves

Certified Quality Auditor ASQ or other certifying body
Certified Quality Manager (CQM)-ASQ ASQ or other certifying body
Software knowledge: MS Office, DocuSign, 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/prioritize workload
Ability to lead cross-functional teams, influence without direct authority, and communicate effectively with internal stakeholders and external suppliers
Good eye for 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 such as FDA QMSR and 21 CFR Part 4 requirements
Assist in the execution of the established risk-based supplier qualification, approval, requalification, and disqualification processes for suppliers, contract manufacturers, contact laboratories, distributors, service providers, and critical material vendors.
Perform GxP Vendor List risk assessments to help develop the annual vendor audit schedule.
Negotiate, establish, maintain and periodically review supplier Technical or Quality Agreements.
Develop vendor Key Performance Indicators and Scorecards. Monitor vendor quality performance through metrics, scorecards, trend analysis, management review inputs, and escalation processes.
Participate as a liaison in vendor quality events such as deviations and nonconformance investigations, OOS events, and CAPA implementation.
Manage the intake and cross-functional coordination of vendor change notifications.
Participate in or initiate vendor quality issue escalation, including material holds, supplier corrective action requests, field impact assessments, recall support and regulatory inspection support as required.
Identify supplier quality trends and drive continuous improvement initiatives.
Ensure vendor-management related records are maintained in accordance with company procedures and retention requirements.
Author, revise, and maintain vendor quality procedures, work instructions, templates, and training materials.