Vice President, Quality Operations – Combination Products

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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.
How you’ll contribute
The Vice President, Quality Operations - Combination Products will oversee all Quality functions associated with United Therapeutics' Dry Powder Inhalation and Soft Mist Inhaler production facilities. These facilities will manufacture, label and package finished drug product and medical devices. This functional site head role ensures these products meet global GMP/GDP regulations, UT quality standards, will drive compliance and will foster a culture continuous improvement. The VP position will provide strategic leadership in regulatory compliance for these drug products and medical devices, lead Health Authority interactions, and support collaboration to achieve operational excellence.

• Oversee Quality Operations, ensuring all aspects of drug product and medical device manufacturing, labeling and packaging comply with GMP/GDP and applicable global regulatory standards
• Provide quality leadership in drug product and medical device manufacturing and packaging activities to facilitate timely product disposition
• Ensure compliance with FDA and other applicable global regulations for drug products and medical devices
• Lead Quality activities related to the facility start-up, including equipment qualification, process validation, and regulatory filings
• Manage Health Authority inspections for the facilities, ensuring audit readiness and successful outcomes
• Collaborate with Manufacturing teams to establish effective quality standards, ensuring functionality and patient safety
• Oversee and approve GMP documentation, including batch records, deviations, validation protocols, and regulatory filings
• Build and maintain Quality Agreements with numerous manufacturing vendors and device suppliers supporting the production of drug products
• Adapt existing quality systems and procedures to current combination product requirements, including design control, risk management, and post-market surveillance
• Evaluate quality systems through routine risk assessments and drive the implementation of corrective and preventive actions (CAPAs) to improve product and process quality
• Lead cross-functional teams in technology transfer activities, ensuring seamless integration of drug and device components into a combination product
• Drive continuous improvement initiatives to enhance manufacturing processes, product quality, and operational efficiency while maintaining compliance
• Collaborate with supply chain teams to ensure the uninterrupted supply of products, meeting the highest quality standards
• Represent the Quality function in leadership meetings, communicating goals and progress to internal stakeholders and regulatory agencies
• Monitor and integrate emerging regulatory requirements for combination products, ensuring the organization remains compliant and proactive in adapting to changes
• Develop and maintain training programs to ensure quality staff are proficient in combination product regulations, quality systems, and manufacturing processes
• Partner with Manufacturing, Regulatory Affairs, and Engineering to support manufacturing scale-up and ensure regulatory submissions meet global expectations
• All other duties as required

Minimum Requirements

• Bachelor’s Degree in scientific discipline with equivalent experience/training
• 15+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical or fine chemicals industry
• 10+ years of management experience, inclusive of 5+ years overseeing both QA and QC functions
• 7+ years of experience in FDA, USP and EP testing requirements
• 5+ years of experience in stability testing programs
• Experience in instrumentation and expertise in HPLC, GC, UV/VIS, FTIR
• Experience in US FDA, EU, and JP GMP regulations
• Experience in analytical method development/validation and lab method transfer protocols
• Experience in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review, writing and application
• Experience in departmental budgeting
• Advanced working knowledge of cGMPs
• Demonstrates exceptional attention to detail
• Exhibits strong organizational skills
• Effective in prioritizing tasks for self and a team
• Able to work independently and collaboratively within a multi-functional team
• Thrives in high-pressure environments, managing heavy workloads and tight deadlines
• Possesses advanced proficiency in MS Office applications, with expertise in MS Word and Excel

Preferred Qualifications

• Master’s Degree in scientific discipline with equivalent experience/training

Job Location

United Therapeutics requires this candidate to be on-site 100% of the time at our RTP, North Carolina location in zipcode 27713. Relocation assistance may be available for non-local candidates.

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.