Senior Manager, Quality Assurance

13 hours, 33 minutes ago
Full-time
Senior
Quality Assurance and Testing
AssistRx

AssistRx

AssistRx is a technology solutions company that connects pharmaceutical and biotech manufacturers with prescribers, patients, and providers. Their flagship product, iAssist, simplifies the prescribing process for specialty therapies, focusing on accura...

Pharmaceuticals
251-1K
Founded 2009

Description

  • Execute day-to-day quality activities supporting patient support program processes, case management documentation, and call documentation.
  • Review 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.
  • Maintain and execute the Quality Management System (QMS) for the patient support program.
  • Author, review, and update quality-related SOPs, work instructions, monitoring tools, and quality plans.
  • Support inspection readiness through document preparation, procedure review, and quality risk assessments.
  • Oversee quality support for adverse event, product complaint, and special situation intake and documentation.
  • Identify quality issues, deviations, and trends through review and data analysis, and support CAPA development and tracking.
  • Partner with Training to develop quality-focused onboarding and continuing education materials and support remediation efforts.
  • Serve as a quality subject matter expert and collaborate cross-functionally on sponsor-facing materials, program launches, and quality impact assessments.

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.
  • Experience supporting client audits, inspection readiness, and regulated quality systems (preferred).
  • Experience with supervisory responsibilities, including hiring, training, performance feedback, and work direction.
  • Strong analytical, judgment, change management, and quality management capabilities.
  • Ability to work cross-functionally with Operations, Compliance, Drug Safety/Pharmacovigilance, Training, and Legal teams.
  • Must be eligible to work in the United States; sponsorship and/or work authorization is not available for this position.

Benefits

  • Competitive pay structure.
  • Matching 401(k) with immediate vesting.
  • Medical, dental, vision, life, and short-term disability insurance.
  • Paid time off.
  • Eight paid holidays each calendar year.
  • Opportunities for growth and promotions within the organization.

Interested in this position?

Apply directly on the company website

Apply Now

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