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

United Therapeutics•Rtp, NC

9h•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a publicly-traded biotech or pharmaceutical company operating as a public benefit corporation, focused on developing novel pharmaceutical therapies and technologies for rare, deadly diseases and expanding the availability of transplantable organs. The company has developed six FDA-approved therapies and is working on manufactured organs to address transplant shortages. This role is for a pharmacovigilance professional who will lead the design, development, and continuous improvement of Global Patient Safety (GPS) training strategies, focusing on training operations, innovation, effectiveness, and measurable outcomes. The position involves partnering with GPS leadership to align training programs with regulatory requirements and business processes, establishing a data-driven training framework, and providing operational support for Quality Records (deviations, CAPAs, effectiveness checks) and Compliance within a lean team. The role also contributes to inspection readiness, audit support, and continuous improvement initiatives to maintain a compliant 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., ICSRs, aggregate reporting, signal detection, PVAs, quality systems)
3+ years of experience supporting quality systems and quality records (e.g., deviations, CAPAs, 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 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 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 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, ensuring application of adult learning principles.
Lead the end-to-end strategy for GPS training programs, ensuring alignment with global regulatory requirements, internal procedures, and adult learning principles.
Design and implement innovative, scalable, and fit-for-purpose training approaches grounded in adult learning theory.
Establish and maintain training effectiveness metrics, incorporating evaluation of knowledge retention and application, and report insights to leadership.
Lead training initiatives, such as conducting training needs analyses based on deviations, CAPAs, audit findings, process changes, and regulatory updates.
Drive continuous improvement of training curricula using industry insights, inspection/audit data, and adult learning methodologies.
Oversee training compliance for GPS staff, vendors, and partners, including identification and escalation of non-compliance.
Lead company-wide adverse event (AE) and serious adverse event (SAE) training for commercial and clinical programs.
Partner with the Training and Development function to monitor training compliance and manage escalation for GPS staff and vendors.
Partner with functional subject matter experts (SMEs) to translate complex PV processes into practical, engaging, and learner-centered training content.
Serve as QTC support for quality records, including deviations, CAPAs, and effectiveness checks.
Support root cause analysis (RCA) and CAPA development, ensuring alignment with training-related risk mitigation.
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 the GPS Quality, Training and Compliance team.
Support identification and escalation of compliance risks, and assist in implementing recommendations to strengthen quality management systems.
Support inspection and audit readiness activities across pre- and post-audit phases, including oversight and tracking of CAPAs.
Serve as a 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 RCA and CAPA development.
Contribute to the development and maintenance of systems and processes supporting the inspection and audit lifecycle.
Support the management, development, and harmonization of GPS governing documents (e.g., SOPs, guidance documents, templates).
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.