Manager, GMP Supplier Quality Management
United Therapeutics Corporation
Summary
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.
Job description
- 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 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
- 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 including identification of impacted UTC sites and evaluation of potential impact to product quality, regulatory filings, validated processes, specifications, labeling and supply continuity
- 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 (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 with a Master's Degree or 2+ years 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
- Demonstrated knowledge of 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
- Preferred: Certified Quality Auditor ASQ or other certifying body
- Preferred: Certified Quality Manager (CQM)-ASQ
- Preferred: Software knowledge: MS Office, DocuSign, electronic QMS systems
- Preferred: Knowledge of AI applications in supplier quality management
- Preferred: Strong organization skills and ability to manage competing priorities
- Preferred: Ability to lead cross-functional teams, influence without direct authority, and communicate effectively
- Preferred: Good eye for detail and commitment to seeing tasks through to completion
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Prescription Coverage
- Employee Wellness Resources
- 401(k) Plan
- Employee Stock Purchase Plan
- Paid Time Off
- Paid Parental Leave
- Disability Benefits
Company overview
United Therapeutics Corporation is an American biotechnology company founded in 1996 with a deeply personal mission: to find a cure for pulmonary arterial hypertension (PAH) after the founder's daughter was diagnosed with this rare disease. Headquartered in Silver Spring, Maryland and Research Triangle Park, North Carolina, the company has evolved into a pioneering force in biotechnology, focusing on developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. United Therapeutics specializes in treatments for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, neuroblastoma, and end-stage lung disease through its flagship products including Tyvaso, Remodulin, Orenitram, Adcirca, and Unituxin. The company is particularly notable for being the first publicly-traded biotech or pharmaceutical company to convert to a public benefit corporation (PBC), with a dual purpose of developing innovative pharmaceutical therapies and creating technologies that increase transplantable organ availability. Their groundbreaking work includes xenotransplantation research, organ manufacturing technologies, and regenerative medicine programs aimed at addressing critical shortages in transplantable organs. With approximately 1,001-5,000 employees and a strong commitment to corporate social responsibility, United Therapeutics has established itself as a leader in both patient-focused innovation and workplace excellence.