QA/QC Manager - DPF - Stewartville

On-Site

Stewartville, MN

Full time

R05374

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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

The QA/QC Manager provides operational and tactical leadership for the on-site Quality Assurance and Quality Control Microbiology function at the Designated Pathogen-Free (DPF) Facility in support of xenotransplantation organ manufacturing. This position is responsible for governing the environmental monitoring program at the site, leading deviation and CAPA management for the microbiology and on-site QA functions.

• Manage Quality Assurance/Quality Control programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products

• Provide operational leadership for the on-site QA / QC microbiology function at the DPF, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness

• Govern the environmental monitoring program for barrier and non-barrier areas of the DPF, including program design review, qualification, periodic trending, signal detection, and continuous improvement

• Serve as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise

• Lead or oversee root cause analysis for microbiological and environmental events; drive timely CAPA execution and effectiveness verification under risk-based prioritization

• Partner with Site Operations, Animal Care, and Facilities to align microbiology and EM controls with operational reality and risk; provide Quality input on facility, process, and equipment changes

• Establish operational metrics and dashboards for the QA / QC microbiology function; report performance, risks, and trends to senior Quality leadership on a recurring cadence

• Drive supplier qualification activities for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audit programs as needed

• Support strategic initiatives related to the DPF Quality Management System (QMS), inspection readiness, right-first-time execution, and continuous improvement

• Act as QA representative in product development meetings, technology transfer, and scale-up activities

• 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

• 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

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 GMP/QSR, FDA regulations, GxP principles, and industry standards, with the ability to apply requirements to company-specific processes, products, and preservation of lungs

• Demonstrated applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations

• Experience supporting regulatory inspections (FDA, USDA, and other agencies) as a subject matter expert

• Direct experience reviewing and approving controlled documents, deviations, CAPAs, change controls, and quality records within electronic quality systems

• Experience leading root cause analysis for microbiological and environmental events; familiarity with risk-based decision-making (e.g., ICH Q9 principles)

• Strong analytical judgment with exceptional problem-solving and risk assessment capabilities

• Ability to interpret data and apply GxP principles to xenotransplantation-specific procedures, processes, and products

• 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

• Expertise in preparing for and managing FDA, EMA, and ISO audits

Preferred Qualifications

• 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

This position is located 100% onsite at our Stewartville, MN facility.

The salary range for this position is $100,000 - 140,000 /yr and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

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.

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.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.