United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.
The job details are as follows:
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have 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 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 Senior Auditor, Global GCP Compliance will ensure all aspects of Clinical Operations/Clinical Development, Regulatory Affairs, and Medical Affairs activities are in compliance with governing regulations, directives, laws, UT QMS, and UT Code of Conduct, where applicable. Conduct audits with remit across GCP activities for United Therapeutics covering qualification & routine evaluations of vendors/supplies (CROs, contracted services and electronic systems, lab facilities, etc.), routine audits of a sample of Clinical Investigator sites conducting UT studies, and internal process & function audits and subsequent follow-up and closure. This is a remote position with up to 50% travel - on average this looks like ~2 trips a month domestically (about 3 days each) and 3-4 international trips per year (about two weeks each).
- Participate in implementing and maintaining a comprehensive risk-based GCP compliance program
- Independently manage, conduct, and report assigned investigator site, vendor, and internal process/function audits on site and remotely according to UT SOPs and using UT systems effectively
- Review and approve audit responses and evaluate adequacy of corrective and/or preventative actions
- Provide SME support during global regulatory agency inspections and third-party audits of the RTP office. Additionally, support inspection and third-party audits of UT vendors and investigator sites.
- Support risk mitigation and continuous improvement initiatives within GxP Compliance and with functional stakeholders, identify and assist in developing and/or updating SOPs and systems needed to comply with regulatory requirements, etc.
- Independently complete vendor qualification assessments and support the maintenance of the GxP Vendor List as needed
- Provide guidance to Clinical Operations, Product Development, Medical Affairs, and Regulatory Affairs ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, UT SOPs, and study requirements
- Independently perform document record review, including general study files and site-specific study files in area of responsibilities
- Perform trend analysis/metrics of audit findings and provide summary reports to management of audit activities
- Participate in GxP Compliance in activities overlapping with GLP, GVP, and GMP/GDP Compliance
- Partner with GCP Compliance leaders to strategize initiatives and plans for development, and assist in coordinating and conducting any functional area/departmental programs
- Assist in setting annual GCP audit schedule and preparing necessary budget
- May support UT, vendor, and investigator site regulatory inspections and third-party audits as needed
- All other duties as required
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a scientific area or other relevant field
- 5+ years of direct GCP auditing experience (vendor, investigator site, and internal process/function audits) in the pharmaceutical industry
- 1+ years of experience working with/using a risk-based auditing approach
- 1+ years of experience understanding and providing guidance regarding global GCP compliance regulations
- 1+ years of experience with GCP CAPAs, trending analysis, and/or risk management
- Auditor certification (i.e. ASQ, SQA) or auditor exam completion (i.e. ISO 9001), or certification obtained within the first 6 months of UT employment as agreed with manager
- Excellent written and verbal communication with strong attention to detail
- Excellent time-management and organization skills with ability to prioritize work according to set timelines and deliverables
- Self-motivated and proactive with ability to work independently and as part of a team (both departmentally and cross-functionally)
- Proficient with MS Office suite (Word, Excel, Outlook, PowerPoint)
- 1+ years of experience conducting audits internationally
- 1+ years of experience and/or familiarity with computer systems audits
- Knowledge of Trackwise Digital, Smartsheet, MasterControl, Veeva, and eTMF, EDC, IVRS, and common analytics platforms
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.
Applicable to Colorado Applicants Only:
- Thesalary rangefor this role at a senior level is[$95-140]
- This role is also eligible for the Company’s incentive plan
- The Company also offers benefits as outlined to eligible employees: https://www.unither.com/careers-benefits.html
- The hourly or 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, seniority, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in Colorado. 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.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities