The Quality Assurance Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) supporting VES and Epidemiology (EPI) services. This role provides leadership for quality governance, audit readiness, compliance, SOP management, CAPA processes, and continuous improvement initiatives while partnering closely with operational, scientific, and client-facing teams to ensure adherence to organizational standards, client requirements, and applicable regulatory expectations.
You'll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.
Primary Responsibilities:- Serve as the Quality Management System (QMS) lead and subject matter expert, partnering with VES and Epidemiology (EPI) teams to embed quality, compliance, and governance practices into daily operations and project delivery
- Establish, maintain, and continuously improve quality management practices for VES and EPI services, including SOPs, controls, governance processes, and quality standards
- Ensure alignment of quality processes and documentation with internal QMS requirements, client expectations, industry best practices, and applicable regulatory requirements
- Develop and coordinate responses to QA/QMS-related client Requests for Information (RFIs), vendor qualification questionnaires, due diligence requests, and quality assessments
- Review and advise on quality-related contractual language to ensure compliance with organizational policies and client requirements
- Maintain and administer the QMS, including SOP development and management, training records, policy attestations, quality documentation, and controlled records
- Organize and monitor key quality activities and timelines, including SOP reviews, audit schedules, training compliance, CAPA tracking, and governance requirements
- Act as the primary point of contact for client audits, vendor audits, and regulatory inspections, including audit planning, scope and agenda coordination, stakeholder preparation, evidence collection, audit facilitation, and follow-up activities
- Lead audit and inspection readiness activities for VES and EPI, ensuring maintenance of inspection-ready artifacts, supporting documentation, quality controls, and evidence repositories
- Manage corrective and preventive actions (CAPAs), including root cause analysis, remediation planning, tracking, and verification of effectiveness
- Partner with internal and external audit teams to assess compliance with quality processes, identify risks, and implement corrective actions
- Conduct internal and vendor audits to evaluate compliance with established procedures, controls, and quality standards
- Develop and maintain quality metrics, reporting, and analysis to monitor performance, identify trends, assess compliance, and drive informed decision-making
- Design, facilitate, and evaluate quality improvement initiatives that strengthen operational effectiveness and support a culture of continuous improvement
- Promote quality awareness, audit readiness, compliance, and operational excellence across VES and EPI
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications:- 3+ years of experience in quality management, compliance, or a related field
- 2 years of experience working in regulated environments (e.g., healthcare, life sciences, data governance)
- Intermediate to Advanced experience with technical writing (i.e. how to create process flows, SOPs using Visio, interview SME and create documented practices. Know how to write non-conformance and corrective actions)
- Intermediate experience with MS Office - Visio
- Demonstrated ability to communicate effectively on a regular basis with Compliance, Legal, Engineering and Data team stakeholders
- Ability to travel up to 10% to Boston, MA office
Preferred Qualifications:- Experience supporting quality reviews, audits, or regulatory readiness activities
- Experience of working within life science sector
- Experience working within a Quality Management System (QMS)
*All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy
Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $91,700 to $163,700 annually based on full-time employment. We comply with all minimum wage laws as applicable.
Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.
