Supervisor, Quality Control - RMOMAL

About the role

The Supervisor of Quality Control (QC) at United Therapeutics is responsible for ensuring timely and accurate testing of raw materials, in-process samples, drug substances, and drug products while maintaining strict compliance with cGMP regulations and United Therapeutics (UT) quality standards. This position involves applying QA expertise in a new field, supporting first-of-their-kind regenerative organ products, and fostering a culture of quality and continuous improvement.

Responsibilities

• Schedule and prioritize laboratory work, reviewing data for accuracy and compliance
• Support investigations and CAPA activities
• Coordinate testing with external contract laboratories, including sample shipment, method transfers, data review, and ensuring compliance with company standards and regulatory requirements
• Conduct and/or provide supervisory oversight of routine OOT/OOS/deviation investigations and CAPA activities related to the laboratory
• Review and approve routine analytical chemistry data packages generated by internal teams and external testing organizations
• Act as primary point of contact for routine testing status in manufacturing, project, and product team meetings
• Support installation/operation/qualification (IQ/OQ/PQ) of new or transferred laboratory equipment
• Assist with implementation of applicable regulatory/compendial changes within the QC Analytical Chemistry laboratory
• Provide supervisory oversight and on-the-job training for Analytical Chemists/Analysts
• Troubleshoot routine instrument and LIMS issues, coordinating with internal resources and vendor technical services to resolve problems

Requirements

• Bachelor’s Degree in chemistry or other scientific discipline
• 5+ years of related experience in a GMP pharmaceutical laboratory
• Applied knowledge of cGMP requirements and QC laboratory practices
• Proficiency in wet chemistry techniques and experience with cell-based assays (e.g., potency testing, viability assays, or similar)
• Familiarity with LIMS and cGMP documentation practices
• Strong written and verbal communication skills to interact cross-functionally and with management
• Experience managing contract laboratory relationships and reviewing external data packages
• Detail-oriented, organized, and self-motivated with the ability to prioritize work in a dynamic environment
• Prior lead experience (e.g., coordinating daily work, mentoring junior analysts, or acting as shift lead)

Qualifications

• Master’s Degree
• 1+ years of people management experience
• Familiarity with OOT/OOS/deviation investigation practices and CAPA execution in QC

Skills

• Wet chemistry techniques
• Cell-based assays
• LIMS and cGMP documentation practices
• Communication skills
• Contract laboratory management
• Quality control procedures
• People management

Benefits

• Comprehensive benefits suite 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

Pay

Competitive salary commensurate with experience

Schedule

Full-time, on-site at United Therapeutics’ Durham, North Carolina location 100% of the time

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