Senior Manager, Clinical Quality Assurance

California, US residents click here. 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 You have experience with early phase to late phase development of trials. You can make decisions around the design of a study determining what is important from a quality perspective, considering compliance for the life cycle of the trial. Writing and managing SOPs, investigations, and performing root cause analysis are all tools in your clinical quality assurance toolbox. The Senior Manager, Clinical Quality Assurance role is responsible for the management and execution of clinical quality oversight activities in support of the organization's active clinical trials, and to maintain compliance to federal and international GCP regulations, as well as internal policies and procedures. This role will interact closely with clinical project team members to provide compliance support in making key trial-related decisions. Minimum Requirements Bachelor’s degree in a scientific or related discipline 10 years of direct biotech/pharmaceutical industry experience 5 years of experience within GCP Quality Experience performing clinical quality assurance functions in CRO and/or Sponsor companies Experience with process and documentation audits; experience developing process documentation; ability to understand and interpret national, regional, and local regulations Preferred Qualifications 2 years in a clinical process or operations role Certified Quality Manager (CQM)-ASQ RQAP-GCP and/or ASQ-CQA Experience providing support with trials crossing into International regulation requirements for the purposes of GCP compliance and EMA expectations Good Laboratory Practice (GLP) experience Job Location & Travel This position is located at our Silver Spring, MD office. Currently this is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs. This position has a travel expectation of up to 25% to conduct site and vendor compliance audits and to attend meetings. 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. The salary for this position ranges from $145,000 to $170,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 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.

Salary : $145,000 - $170,000