AssistRx

Senior Manager, Quality Assurance

AssistRx

full-time

Posted on:

Location Type: Remote

Location: Florida • United States

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Job Level

Senior

About the role

  • - 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assurancecompliancecase managementSOP executiondocumentation reviewroot cause analysiscorrective and preventive actionspharmacovigilancequality management systemdata analysis
Soft Skills
analyticalbusiness acumenchange managementinterpersonal skillsjudgmentorganizational supportstrategic thinkingethicsmanaging peoplediversity