Senior Manager, Quality Assurance

Role Overview

• 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
• 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.

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
• Analytical, Business Acumen, Change Management, Diversity, Ethics, Interpersonal Skills, Judgement, Managing People, Organizational Support, Quality Management, Strategic Thinking.

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.