Manager, GMP Supplier Quality Management

California, US residents. The job details are as follows:

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases.

We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need.

For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

• 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,…