United Therapeutics Auditor, GCP Quality Systems in Durham, North Carolina
The Job Details are as follows:
What we do
United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market and a long-term mission of providing and unlimited supply of transplantable organs for those who need them. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
How you’ll contribute
The Auditor GCP Quality Systems will assist in all aspects of clinical compliance and QA activities, including documentation review, internal process audits and external site and vendor audits and follow-up, providing guidance to clinical operations, data management and statistics, and drug safety, ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, United Therapeutics SOPs, and study requirements.
Assist in implementing and maintaining a comprehensive GCP compliant quality program.
Plan and conduct external site and vendor audits according to UT SOPs.
Assist in reviewing audit responses and evaluation adequacy of corrective actions/preventative actions (CAPAs).
Assist with regulatory agency and other audits/inspections of RTP office, UTEL office, and clinical sites.
Assist in identifying and developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements.
Plan and conduct internal clinical process audits according to UT SOPs.
Perform quality assurance reviews of Investigator’s Brochures, Clinical Study Reports and other study documentation as necessary.
Perform document record review including, general study files, site specific study files, clinical and pharmacological, etc.
Perform trending analysis/metrics of audit findings and assist in providing summary reports to management of audit activities.
Assist in the coordination and conduct of clinical/departmental training programs.
For this role you will need
5+ years or relevant pharmaceutical industry experience which includes at least 2+ years of direct GCP auditing experience
Working knowledge of GCP/ICH regulations and guidelines. Experience with international regulatory practices
Good eye for detail and commitment to seeing tasks through to completion
Experience and comfort in working both independently and as part of a multifunctional team
Proven organizational skills and strong ability to prioritize workload
Commitment and ability to handle high workloads, stressful situations, and deadlines
Both domestic and international travel required to conduct site and vendor compliance audits. Up to 50% travel may be required
Experience with clinical CAPAs, trending analysis, and/or pharmacovigilance audits
Microsoft Office proficient
Life as a Unitherian
At United Therapeutics you’ll realize quickly that it is not an ordinary place to work! When you join our Company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. 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 of job performance and provide state of the art facilities to flourish. This is what makes united Therapeutics a stimulating place to work.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. 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.