Manager, GMP Supplier Quality Management

On-Site

RTP, NC

Full time

R05231

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

The job details are as follows:

Who We Are

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.

Who You Are

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

Minimum 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.

Preferred Qualifications

• 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

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.