Associate Quality Assurance Manager - Organ Manufacturing

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.

In 2021, we became 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.

How you’ll contribute
The Associate Quality Assurance Manager will manage quality assurance systems, activities and compliance related to the manufacturing and assessment of lungs in a cGMP/QSR environment.

• Lead Quality Assurance team to support regulatory and clinical efforts to reach FDA approval of manufactured organs
• Review documentation (i.e. analytical / medical records, clinical case records, protocols, reports, environmental monitoring data, Device Design History Files, laboratory data, etc.) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and GMP/QSR/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. Requires 24/7 availability for procedure/data review (which can be done remotely).
• 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, 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; as assigned by Quality management, 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 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
• Other duties as assigned
• *This position requires working in-person from our Manchester office five days per week, when not on business travel*

For this role you will need

Minimum Requirements

• Bachelor’s Degree in Arts/Sciences (BA/BS) in science or engineering or equivalent experience
• 6+ years of experience in a GMP/QSR regulated environment and/or at least six years of experience in tissue bank and/or cell processing environment
• Applied knowledge of GMPs/QSR, FDA guidelines, and industry standards; Ability to apply GMP to company specific processes and products in the assessment and preservation of lungs
• Excellent professional documentation skills
• Ability to objectively, accurately, and thoroughly convey complex issues 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
• Skills in performing presentations and leading meetings
• Ability to interpret data in relation to a vast number of company procedures as well as current GMP/QSR/GCP 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

Preferred Qualifications

• TrackWise and MasterControl (eDMS) 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