Quality Assurance Manager - RMOMAL

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

You're an experienced quality professional excited about the challenge of supporting a greenfield site and creating a culture of quality and accountability from the ground up. You'll be supporting first of their kind regenerative organ products and will be uniquely challenged to apply your QA expertise in a brand new field. The Quality Assurance (QA) Manager will provide oversight and leadership for QA activities within a regenerative organ manufacturing GMP facility. This role ensures compliance with FDA regulations, Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and clinical trial requirements to support the development and commercialization of advanced therapeutic products. The QA Manager will collaborate cross-functionally to maintain a robust Quality Management System (QMS), drive continuous improvement, and support regulatory submissions and inspections.

• Manage Quality Assurance programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products
• Act as QA representative in product development meetings, technology transfer, and scale-up activities
• Ensure compliance with data integrity principles (ALCOA+) across electronic systems and laboratory records
• Drive process optimization and efficiency improvements using Lean or Six Sigma methodologies
• Review documentation (e.g., analytical/medical records, clinical case records, protocols, reports, environmental monitoring data, Device Design History Files, laboratory data) for accuracy, completeness, and compliance with company policies, procedures, and GMP/QSR/Clinical Trial requirements
• Oversee supplier qualification, audits, and ongoing performance monitoring to ensure raw materials and components meet GMP standards
• Perform internal and vendor audits; track corrective actions and manage audit files; summarize data for annual product reports
• Conduct QA oversight activities, including deviation/failure investigations, change control documentation, complaints, SOPs, and product quality reviews
• Lead risk assessments and Corrective and Preventive Action (CAPA) programs to proactively address quality issues and prevent recurrence
• Lead controlled document collaboration, review, and approval within the electronic document management system
• Establish and track key quality indicators (KPIs); present trends and risk analysis to senior leadership
• Provide real-time review of clinical case data, which may require procedure and data review outside of normal business hours
• Develop, implement, and maintain the laboratory Quality Management System (QMS)
• Review, write, and update SOPs and reports
• Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of projects
• Develop and provide guidance on new initiatives and quality improvements; assess internal processes for efficiency
• Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion
• Stay current on regenerative medicine, tissue engineering, and organ manufacturing technologies to align QA practices with innovation
• Perform other duties as assigned

For this role you will need

Minimum Requirements

• 8+ years of experience in a GMP/QSR regulated environment with a Bachelor's Degree or 6+ years of experience in a GMP/QSR regulated environment with a Master's Degree
• 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
• Ability to interpret data in relation to company procedures and regulatory requirements (GMP/QSR/GCP)
• Ability to mentor and develop QA team members
• Experience in review/audit of medical & Quality records
• Exceptional skills in problem and risk analysis/assessments
• Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
• Excellent professional documentation skills
• Ability to objectively, accurately, and thoroughly convey complex issues in writing
• Ability to produce a high volume of written materials independently
• Effective cross-functional collaboration and communication skills, including leading meetings and presentations
• Proficiency in MS Excel, PowerPoint, Word, and Outlook
• Ability to handle confidential company data, projects, information, etc.

Preferred Qualifications

• Expertise in preparing for and managing FDA, EMA, and ISO audits
• Ability to lead organizational change related to quality systems and compliance
• Experience contributing to IND, IDE, or BLA submissions
• Experience with TrackWise and MasterControl (eDMS)
• Experience creating and implementing a QMS

Job Location

United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.