United Therapeutics Manager, Quality Assurance in Jacksonville, Florida

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 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

To support the launch of our second Lung Bioengineering (LB2) facility in Jacksonville, FL, we are looking for a Manager, Quality Assurance. In this role, under the guidance of and collaboration with colleagues at the LB1 facility in Maryland, you will manage the quality assurance systems, activities, and compliance related to the preservation and assessment of lungs in a 24/7 cGMP/QSR environment. As the quality assurance primary point of contact for LB2, you will be responsible for all Quality activities including; documentation review, raw material review, inspection, and release. In addition, you will be the initial point of contact for any FDA (or other regulatory agency) site inspections and provide real-time/daily Quality guidance for the site. You will also help manage third-party vendors and perform audits as necessary. Lastly, as the site is still currently under development, you will oversee all necessary construction to ensure compliance measures are achieved.

  • Review documentation for accuracy, completeness, and compliance with internal and GMP/QSR policies, procedures, Clinical Trial requirements

  • Perform raw material review/inspection and release

  • Manage and lead controlled document collaboration, review and approval

  • Provide real-time review of clinical case data with periodic 24/7 availability for procedure/data review

  • Perform quality assurance oversight activities to ensure compliance with current regulatory standards

  • Review and write/update SOPs and reports to support these systems

  • Perform internal and vendor audits, track corrections and summarize audit observations and manage internal and external audit files

  • Assist Operations, Quality, and R&D, in the preparation of validation protocols and reports

  • Coordinate validation plans and tasks to assure timely completion of validation projects

  • Develop, provide guidance and direction regarding new initiatives and quality improvements

  • Assess internal processes and procedures to ensure the most efficient utilization of resources

  • Provide strategic advice and support to senior management and staff

  • Assist management during FDA or other regulatory agency inspections

  • Interpret direction of any inspections and react accordingly and quickly to mitigate potential problems

  • Act with discretion and support the timely and accurate transfer of data, documents, and information to inspectors

  • Other duties as assigned

For this role you will need

Minimum Qualifications

  • Ability to initially work at headquarters in Silver Spring Maryland for a period of 2-3 months

  • Bachelor’s degree in a scientific or engineering discipline

  • 6+ years of experience in cGMP/QSR or GTP regulated environment

  • Working knowledge of Microsoft Office

  • 10% Travel as needed

Preferred Qualifications

  • Experience in tissue bank and/or cell processing environment

  • 1+ years of experience in transplantation environment

  • CQA/AATB certification

  • Experience with TrackWise and MasterControl (eDMS)

  • Experience working with Electronic Medical Records

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.