Senior/manager, QA Operations (combination Products)

Senior/Manager, QA Operations, Combination Products

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.

You'll be at the center of ensuring quality isn't just compliant—it's exceptional. This role is ideal for a hands-on quality leader who enjoys building and guiding high-performing teams, partnering cross-functionally, and translating complex cGMP requirements into efficient, real-world operations. You'll oversee daily quality activities supporting clinical and commercial drug product manufacturing, lead key initiatives across batch record review, deviations, CAPAs, and inspections, and serve as a trusted point of contact for both internal teams and external partners. The Senior/Manager, QA Operations, Combination Products will be responsible for managing Quality Operations personnel and daily activities in support of Drug Product processes in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures. The position will build and lead an effective, high-performance team to meet current and future business needs to support United Therapeutics drug pipelines.

Develop and manage personnel and department goals and objectives to foster accountability, process initiatives and support corporate milestones Participate in onboarding and recruitment processes of new hires (recruitment, meetings, interviews, evaluations, software access, etc.) Manage and prioritize departmental work assignments and allocation of resources (bulk labeling activities, batch record and raw material review and disposition, area clearances, AQL inspections, floor support, etc.) to ensure tasks are completed Manage the review and disposition of manufacturing and packaging batch records and raw materials and components for clinical and commercial processes Create, revise and approve standard operating procedures (SOPs), work instructions and bulk label masters Review and approve master batch records, test methods and raw material specifications in the electronic document management system Review product specifications in the electronic document management system for clinical and commercial products Manage quality events, CAPAs and change controls assigned to Quality Operations to support cGMP processes Manage key performance indicators, metrics, trends and corrective actions for Quality Operations. Effectively communicate data driven results and recommendations to senior leaders. Act as the primary point of contact (POC) for internal departments and third-party partners regarding Quality Operations activities. Interpret potential issues and recommend best practices and solutions. Escalate unresolved issues or concerns to Quality Management and affected area management. Communicate the management of routine operations, including department workflow status, resources, strategies, quality issues, etc. to Quality Operations Director or Senior Quality Management Manage Quality Operations responsibilities for site cross functional initiatives and quality projects to ensure a harmonized approach across the organization, including project plans, timelines, deliverables, etc. Manage Quality Operations responsibilities for client/projects meetings, including manufacturing activities, non-conformance events, batch records, developmental strategies etc. to support product pipelines Participate in department budgetary and resource management, including identifying department gaps, vendor contracts and assessments, resource allocation, personnel assessments, etc. Act as the subject matter expert for regulatory authority (FDA, MHRA, QP, etc) inspections and internal audits. Manage department assigned internal and regulatory authority audit responses . Manage Quality Operations and Document Control personnel to include professional development, performance evaluations, goal setting & achievement, coaching, mentoring, job description evaluations, productivity, training curriculum's, etc. Perform other duties as assigned

Minimum Requirements:

• Manager, QA Operations (Combination Products) Bachelor's Degree in a scientific or related technical discipline 8+ years of relevant pharmaceutical industry experience in a cGMP regulated environment with a Bachelor's Degree or 6+ years of relevant pharmaceutical industry experience in a cGMP regulated environment with a Master's Degree 2+ years of supervisory experience (personnel and/or systems) Ability to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, personnel, stressful situations, deadlines based on business needs, compliance and product risk Ability to demonstrate the initiative to solve problems independently and exercise good judgment and discretion Experience in review of batch records, production records, process control records Ability to handle confidential company data, projects, information, etc. Effective interpersonal, written and verbal communication skills
• Senior Manager, QA Operations (Combination Products) Bachelor's Degree in a scientific or related or related technical discipline or 10+ years of relevant pharmaceutical industry experience in a GMP related environment with a Bachelor's Degree or 8+ years of relevant pharmaceutical industry experience in a GMP related environment with a Master's Degree 4+ years of supervisory experience Ability to work independently and as part of a multi-functional team, able to manage and prioritize workloads, personnel, stressful situations, deadlines based on business needs, compliance and product risk Ability to demonstrate the initiative to solve problems independently and exercise good judgment and discretion Experience in document management, data and record review Ability to handle confidential company data, projects, information, etc. Effective interpersonal, written and verbal communication skills Proficient in computer systems to include MS Word, Adobe and Excel, etc.

Preferred Qualifications:

• Master's Degree in a scientific or related technical discipline Knowledge of Enterprise Resource Planning System (ERP), Trackwise Digital, Systems Application and Products (SAP S4HANA), and electronic document management systems

This role is located 100% onsite in RTP, NC.