Senior GPS & PV, Quality Control, Compliance & Training Manager

United Therapeutics Corporation•RTP, NC, NC

3d•Hybrid

About The Position

This role will lead the design, development, and continuous improvement of Global Patient Safety (GPS) training strategies, with a focus on training operations, innovation, effectiveness, and measurable outcomes. This person will partner with GPS functional leadership and peers to ensure training programs are aligned with regulatory requirements, evolving business processes, and innovative learning approaches, and will establish and maintain a robust, data-driven training framework to assess knowledge retention, training effectiveness, and compliance across internal staff, vendors, and partners. In addition to core training responsibilities, this role will provide operational support across Quality Records (e.g., deviations, Corrective and Preventive Actions, Effectiveness Checks, etc.) and Compliance to ensure continuity of Quality, Training, and Compliance (QTC) activities within a lean team structure, and will contribute to inspection readiness, audit support, and continuous improvement initiatives to sustain a compliant and inspection-ready GPS Quality Management System (QMS).

Requirements

Bachelor’s Degree in nursing, pharmacy, life sciences, or a related healthcare/scientific discipline, and 10+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology, or pharmaceutical industry, OR Master’s Degree in a scientific, healthcare, or education-related discipline (e.g. public health, clinical education, instructional design), and 8+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry, OR PharmD, or equivalent healthcare professional qualification, and 5+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry
5+ years of experience applying global pharmacovigilance regulations and processes (e.g., Individual Case Safety Reports [ICSRs], aggregate reporting, signal detection, Pharmacovigilance Agreements [PVAs], quality systems)
3+ years of experience supporting quality systems and quality records (e.g., deviations, Corrective and Preventive Actions [CAPAs], root cause analysis [RCA])
3+ years of experience supporting audits and regulatory inspections, including inspection readiness and CAPA management
Demonstrated passion for training, learning innovation, and continuous capability development within a regulated environment, including application of adult learning principles
Ability to translate complex clinical, regulatory, and pharmacovigilance concepts into clear, practical, and effective training solutions for diverse audiences using learner-centered and adult learning approaches
Strong pharmacovigilance knowledge, including global regulations, processes (e.g., PV Operations, Safety Risk Management, Affiliate, Alliance, and Contracts, PV Systems), and quality systems, with the ability to apply this knowledge to training and compliance activities
Strong communication and collaboration skills, with the ability to engage stakeholders and drive alignment across functions to support training and compliance objectives
Ability to adapt to changing business needs and priorities within a dynamic, regulated environment
Proven ability to drive results, including supporting Corrective and Preventive Actions (CAPAs), root cause analysis, and continuous improvement initiatives, including identification of training-related gaps and learning interventions
Apply working knowledge of pharmacovigilance processes and requirements to complex situations arising from inspections/audits
Strong analytical thinking, including the ability to interpret data and translate insights into actionable training and process improvements, including evaluation of training effectiveness and knowledge retention
Working knowledge of Quality Management Systems (QMS), including training and GPS processes and procedures (e.g., SOPs, PVAs)
Understanding of audit and inspection processes, including planning and inspection readiness activities
Ability to operate effectively in a fast-paced, evolving environment and provide cross-functional support within a lean Quality, Training, and Compliance (QTC) team
Strategic thinking; ability to analyze opportunities and issues from a broad, long-term perspective, including advancement of training innovation and effectiveness strategies
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Nice To Haves

Registered Nurse (RN)
Master’s Degree in a scientific, healthcare, or education-related discipline (e.g., public health, clinical education, instructional design), or Doctor of Pharmacy (PharmD) /RPh, or equivalent healthcare professional qualification
5+ years of experience in pharmacovigilance training, education, or capability development (e.g., curriculum design, training delivery, training program oversight, and application of adult learning principles to enhance engagement and knowledge retention)
Ability to design, deliver, and measure training effectiveness using data, performance metrics, quality trends, and inspection outcomes, with a focus on knowledge retention and application of adult learning methodologies
Proficiency in pharmacovigilance systems and understanding of Learning Management Systems (LMS), with the ability to optimize training delivery, tracking, and reporting, including support for modern learning approaches (e.g., microlearning, spaced reinforcement)
Experience in developing and assessing training effectiveness using metrics, quality trends, or audit/inspection outcomes
Experience working in a healthcare professional role (e.g., nursing, pharmacy) or applying clinical knowledge to pharmacovigilance activities
Experience implementing innovative or modern learning strategies scenario-based training, experiential learning, spaced reinforcement) within a regulated environment

Responsibilities

Lead the GPS Training program, including curriculum development, training assignments, training compliance, and document management of key GPS training material ensuring application of adult learning principles to support engagement and knowledge retention
Lead the end-to-end strategy for GPS training programs, ensuring alignment with global regulatory requirements and internal procedures and adult learning principles that promote practical application and learner-centered design
Design and implement innovative, scalable, and fit-for-purpose training approaches grounded in adult learning theory (e.g., experiential learning, scenario-based training, spaced reinforcement) to improve knowledge retention and operational performance
Establish and maintain training effectiveness metrics (e.g., knowledge assessments, trending, inspection readiness indicators) incorporating evaluation of knowledge retention over time and application of learning and report insights to leadership
Lead training initiatives, such as conducting training needs analyses based on deviations, Corrective and Preventive Actions (CAPAs), audit findings, process changes, and regulatory updates and translating these into targeted, risk-based learning interventions
Drive continuous improvement of training curricula using industry insights and inspection/audit data, and adult learning methodologies to enhance training impact and sustained competency
Oversee training compliance for GPS staff, vendors, and partners, including identification and escalation of non-compliance, while ensuring training approaches are effective for diverse adult learner populations
Lead company-wide adverse event (AE) and serious adverse event (SAE) training for commercial and clinical programs, including training associated with study documents applicable to PV activities incorporating scenario-based and application-focused learning approaches aligned with real-world pharmacovigilance activities
Partner with the Training and Development function to monitor training compliance and manage escalation of non-compliance for GPS staff and vendors while continuously enhancing learning strategies based on adult learning best practices
Partner with functional subject matter experts (SMEs) to translate complex PV processes (e.g., Individual Case Safety Reports [ICSRs], signal detection, aggregate reporting) into practical, engaging, and learner-centered training content that supports critical thinking and real-world application
Serve as QTC support for quality records, including deviations, CAPAs, and effectiveness checks (as needed)
Support root cause analysis (RCA) and CAPA development, ensuring alignment with training-related risk mitigation where applicable
Contribute to tracking and trending of quality events to identify opportunities for continuous improvement
Provide cross-functional coverage to ensure continuity of QTC operations
Contribute to the development, tracking, and reporting of compliance, quality, and performance metrics for GPS Quality, Training and Compliance team
Support identification and escalation of compliance risks, and assist in implementing recommendations to strengthen quality management systems across the GPS team
Support inspection and audit readiness activities across pre- and post-audit phases, including oversight and tracking of Corrective and Preventive Actions (CAPAs) to ensure timely closure and effectiveness
Serve as a Quality, Training, and Compliance (QTC) subject matter expert (SME) during audits and inspections, supporting responses and providing training-related expertise
Act as the training SME or contributor for GPS quality events, including support of root cause analysis (RCA) and CAPA development for findings, observations, and near misses
Contribute to the development and maintenance of systems and processes supporting the inspection and audit lifecycle, in collaboration with the GPS team to support positive regulatory outcomes
Support the management, development, and harmonization of GPS governing documents (e.g., Standard Operating Procedures [SOPs], guidance documents, templates), ensuring clarity, consistency, and regulatory compliance
Partner with GPS functional leadership to identify the need for new or revised procedures, and ensure appropriate implementation and associated training
Drive alignment between procedural updates and training implementation to ensure effective adoption and sustained compliance
Perform other duties as assigned