Senior Manager, Quality Assurance

About AssistRx

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: 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 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.

Quality Systems & Documentation

• 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

Regulatory & Compliance Support

• 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

Pharmacovigilance & Safety Quality Support

• 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

Issue Management & Continuous Improvement

• 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

Training & Performance Support

• 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

Cross-Functional Collaboration

• 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.

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 directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. 

QUALIFICATIONS:

• 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

COMPETENCIES:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.

• 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, and
• Through proven success, motivation, and team work, potential for growth and promotions within the organization.

AssistRx, Inc. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors, or any other protected categories protected by federal, state, or local laws.

All offers of employment with AssistRx are conditional based on the successful completion of a pre-employment background check.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Sponsorship and/or work authorization is not available for this position.

AssistRx does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of AssistRx and no fee will be paid in the event of a hire.