Vice President, Quality Assurance - Organ Programs

California, US residents click here (https : / / www.unither.com / docs / UNITHER Applicant Notice - (12-22-23) Final 2.15.24 Combined EN and French.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 daughters 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

Are you ready to be part of something truly groundbreaking? As Vice President of Quality Assurance Organ Programs at United Therapeutics, youll play a critical role in shaping the future of transplantation. This is a rare opportunity to lead quality assurance efforts for cutting-edge bioartificial and animal-derived organs designed for human transplant. Youll oversee quality systems across complex cGxP environments, ensuring manufacturing, laboratory, and clinical assessment processes meet the highest regulatory standardshelping pave the way for FDA approval and beyond.

This role is more than just complianceits about innovation, collaboration, and making a real difference. Youll work closely with Regulatory Affairs, Clinical Operations, and Manufacturing to develop robust quality systems that support the advancement of transplantable organ technology. With expertise in risk management, validation, and evolving industry standards, youll ensure operational excellence while pushing the boundaries of whats possible in organ transplantation. If youre passionate about quality, regulatory strategy, and being at the forefront of life-changing medical advancements, we want to hear from you.

Minimum Requirements

Bachelor's Degree in science, engineering, or related field

15 years of progressive leadership in a GxP / FDA / USDA regulated environment

12 years of experience in clinical or commercial animal husbandry / tissue bank and / or cell processing environment and / or biological product manufacturing environment

10 years of proven success in managing and developing high-performing teams

Strong people leadership skills and demonstrated success in the management of complex staff and organizational issues

Experience managing FDA inspections

Applied knowledge of GxPs / Quality Systems, USDA / FDA guidelines, and industry standards

Ability to apply GxP to company specific processes and products in the assessment and preservation of organs for transplant

Experience in review / audit of medical & quality records

Exceptional skills in problem and risk analysis / assessments

Skilled in performing presentations and leading meetings

Ability to interpret data in relation to a vast number of company procedures as well as current GxP / Quality Systems / USDA / etc. requirements

Advanced analytical thought, judgment, and in-depth Quality Assurance knowledge

Competency in conflict resolution, change management, coaching, and professional development

Ability to handle confidential company data, projects, information, etc.

Must not have interaction with pigs outside of the company

Preferred Qualifications

Master's degree in science, engineering, or related field

TrackWise and MasterControl (eDMS) experience

Laboratory Information Management Systems (LIMS) knowledge and experience

SAP S / 4HANA experience

Job Location

United Therapeutics requires this candidate to live near one of our standing facilities, preferably on the east coast. This position requires working in-person from our facilities five days per week, when not on business travel. Relocation assistance is available as required.

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 Companys 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

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity / Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / 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.