Senior Manager, Quality Assurance

AssistRx • Orlando, FL

10h

About The Position

AssistRx 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: T he 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.

Requirements

• Bachelor’s degree in healthcare, life sciences, business, or a related field
• 6–8+ years of experience in quality assurance, compliance, or patient support program operations
• Direct experience supporting pharma-sponsored patient support programs
• Strong working knowledge of HIPAA, privacy regulations, FDA post-marketing requirements, and pharmacovigilance processes
• Demonstrated hands-on experience with SOP execution, documentation review, and issue management

Responsibilities

• Execute day-to-day quality activities supporting patient support program processes, case management documentation, and call documentation
• Perform quality reviews of evaluated calls, documentation, and service outputs to ensure compliance with sponsor-approved procedures and work instructions
• Provide real-time quality guidance and issue identification to support consistent and compliant program execution
• Participate in client audits as needed.
• Participate in the maintenance and execution of the Quality Management System (QMS) for the patient support program
• Author, review, and update quality-related SOPs, work instructions, monitoring tools, and quality plans
• Ensure documentation meets pharmaceutical sponsor, regulatory, and inspection-readiness standards
• Support compliance with applicable laws and regulations, including HIPAA, state privacy requirements, and FDA post-marketing expectations
• Participate in inspection readiness activities through document preparation, procedure review, and quality risk assessments
• Partner with Compliance and Legal teams to evaluate quality and compliance risks related to patient services
• Provide quality oversight for adverse event (AE), product complaint (PC), and special situation intake and documentation
• Ensure safety-related data is accurately captured, documented, and escalated in accordance with sponsor and SOP requirements
• Support pharmacovigilance activities through quality trending, issue escalation, and procedural enhancements
• Assist with safety-related inquiries, quality investigations, and inspection or sponsor requests
• Identify quality issues, deviations, and trends through ongoing review and data analysis
• Perform root cause analysis and support development and tracking of corrective and preventive actions (CAPAs) for the QA related CAPA’s
• Recommend and implement process improvements to strengthen compliance, quality, and patient experience
• Partner with Training teams to develop and maintain quality-focused onboarding and continuing education materials
• Work 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 Supervisors
• Support remediation efforts related to quality or documentation gaps
• Serve as a quality subject matter expert for patient support program processes
• Contribute to sponsor-facing materials such as quality summaries, metrics, and program updates
• Collaborate across functions to ensure changes are assessed for quality impact and implemented compliantly
• Support 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.

Benefits

• Competitive pay structure
• Matching 401(k) with immediate vesting
• Medical, dental, vision, life, & short-term disability insurance
• Paid time off and eight (8) paid holidays throughout the calendar year
• Through proven success, motivation, and team work, potential for growth and promotions within the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees