Associate Quality Assurance Director, Xenotransplantation/Quality Assurance Director, Xenotransplantation
Associate Quality Assurance Director, Xenotransplantation/Quality Assurance Director, Xenotransplantation
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
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, and other orphan diseases.
How you’ll contribute
The Associate Quality Assurance Director, Xenotransplantation will manage quality assurance systems, activities and compliance related to the manufacturing and assessment of animal organs intended for human transplantation in a cGxP (current good clinical/laboratory/manufacturing practice) environment.
- Lead Quality Assurance to support regulatory and clinical efforts to reach FDA approval of animal organs for human transplant
- Review documentation (including, but not limited to: animal care records, analytical/medical records, clinical case records, protocols, reports, environmental monitoring data, and laboratory data) for accuracy, completeness, and compliance with United Therapeutics policies and procedures, and GxP/FDA/Clinical Trial/USDA requirements
- Perform raw material review/inspection and release
- Manage and lead controlled document collaboration, review, and approval
- Provide prompt review of clinical case data
- Perform Quality Assurance oversight activities to ensure compliance with current regulatory standards (e.g. deviation/failure investigations, change control documentation management, complaints, standard operating procedures, and product quality review)
- Review and write/update SOPs and reports to support these systems
- Perform internal and vendor audits; track corrections to audit observations and manage internal and external audit files; summarize data to support annual product reports
- Assist Operations, Quality, and R&D in the preparation of validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of validation projects as assigned by Quality management
- Contribute significantly to Quality Assurance policies, practices, programs, and strategy
- Develop and 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
- Lead FDA/USDA or other regulatory agency inspections; interpret direction from the inspection and react accordingly and quickly to mitigate potential problems; support the timely and accurate transfer of data, documents, and information to inspectors; act with discretion
- Responsible for overall planning, staffing, budgeting, and managing expenses
- Manage, coach, provide feedback, and review team's work, providing mentorship and professional development
- Perform other duties as assigned
For this role you will need
Minimum Requirements
- Bachelor’s Degree in Arts/Sciences (BA/BS) in science, engineering, or related field
- For Associate Quality Assurance Director level: 12+ years of experience in a GxP/FDA/USDA regulated environment
- For Quality Assurance Director level: 15+ years of experience in a GxP/FDA/USDA regulated environment
- Extensive previous managerial experience
- 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
- Excellent professional documentation skills
- Ability to objectively, accurately, and thoroughly convey complex issues verbally and in writing
- Ability to produce a large volume of written materials independently
- 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
- Ability to interact with other departments effectively
- Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
- Ability to handle confidential company data, projects, information, etc.
- Possess working knowledge of MS Excel, PowerPoint, and Word, and Outlook
- This position requires working in-person from our facilities five days per week, when not on business travel
- Must not have interaction with pigs outside of the company
Preferred Qualifications
- 12+ years of experience in animal husbandry/tissue bank and/or cell processing environment
- For Associate Quality Assurance Director level: 6+ years of people management experience
- For Quality Assurance Director level: 8+ years of people management experience
- TrackWise and MasterControl (eDMS) experience
- Laboratory Information Management Systems (LIMS) knowledge and experience
- SAP S/4HANA experience
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.
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