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about 1 month ago
Requirements and responsibilities
About AssistRxAssistRx blends innovative technology with deep healthcare expertise to help life sciences companies improve patient access, visibility, and outcomes. Our solutions simplify complex therapy initiation and reimbursement processes, enabling patients to start and stay on the treatments they need.As a growing health-tech organization, we partner with leading pharmaceutical and biotechnology companies to navigate an evolving healthcare landscape. At AssistRx, our people are our greatest asset—we foster a collaborative, high-performance culture where employees are empowered to grow, innovate, and make a meaningful impact on patient lives.SUMMARY: The Senior Quality Assurance (QA) Manager is a hands-on quality leader responsible for executing and maintaining quality activities that support compliant, high-quality patient services. This role focuses on quality systems execution, monitoring quality outputs, supporting pharmacovigilance requirements, and ensuring adherence to manufacturer-approved standards, processes, and regulatory expectations.The Senior QA Manager works closely with internal cross-functional teams, including Operations, Compliance, Drug Safety/Pharmacovigilance, and Training, to support quality oversight, risk mitigation, and continuous improvement in a regulated environment.DUTIES AND RESPONSIBILITIES:Execute day-to-day quality activities supporting patient support program processes, case management documentation, and call documentationPerform quality reviews of evaluated calls, documentation, and service outputs to ensure compliance with sponsor-approved procedures and work instructionsProvide real-time quality guidance and issue identification to support consistent and compliant program executionParticipate in client audits as needed.Quality Systems & DocumentationParticipate in the maintenance and execution of the Quality Management System (QMS) for the patient support programAuthor, review, and update quality-related SOPs, work instructions, monitoring tools, and quality plansEnsure documentation meets pharmaceutical sponsor, regulatory, and inspection-readiness standardsRegulatory & Compliance SupportSupport compliance with applicable laws and regulations, including HIPAA, state privacy requirements, and FDA post-marketing expectationsParticipate in inspection readiness activities through document preparation, procedure review, and quality risk assessmentsPartner with Compliance and Legal teams to evaluate quality and compliance risks related to patient servicesPharmacovigilance & Safety Quality SupportProvide quality oversight for adverse event (AE), product complaint (PC), and special situation intake and documentationEnsure safety-related data is accurately captured, documented, and escalated in accordance with sponsor and SOP requirementsSupport pharmacovigilance activities through quality trending, issue escalation, and procedural enhancementsAssist with safety-related inquiries, quality investigations, and inspection or sponsor requestsIssue Management & Continuous ImprovementIdentify quality issues, deviations, and trends through ongoing review and data analysisPerform root cause analysis and support development and tracking of corrective and preventive actions (CAPAs) for the QA related CAPA’sRecommend and implement process improvements to strengthen compliance, quality, and patient experienceTraining & Performance SupportPartner with Training teams to develop and maintain quality-focused onboarding and continuing education materialsWork with the Special Projects QAU team on improving the training program and content.Provide direct feedback and coaching recommendations based on quality findings to QA Specialists, QA Team Leads and QA SupervisorsSupport remediation efforts related to quality or documentation gapsCross-Functional CollaborationServe as a quality subject matter expert for patient support program processesContribute to sponsor-facing materials such as quality summaries, metrics, and program updatesCollaborate across functions to ensure changes are assessed for quality impact and implemented compliantlySupport new program launches from a quality perspective.Assist with the development of Program Criteria and the review and approval process with operations and the client.SUPERVISORY RESPONSIBILITIES:Directly supervises employees within the Patient Solutions department.Indirectly supervises employees within the Patient Solutions department.Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.Responsibilities include interviewing, hiring, and training employees; planning, assigning, and
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