Quality Assurance Manager - Research Services

Posted 5 Days Ago
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Eden Prairie, MN, USA
In-Office
92K-164K Annually
Mid level
Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
The Role
Lead and maintain the Quality Management System (QMS) for VES and Epidemiology services. Oversee SOPs, audit readiness, CAPA, vendor and client quality assessments, internal/vendor audits, training records, quality metrics, and continuous improvement while partnering with operational, scientific, and client-facing teams to ensure compliance with internal standards and regulatory expectations.
Summary Generated by Built In
Requisition Number: 2372415
Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us to start Caring. Connecting. Growing together.
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.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

Skills Required

  • 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 technical writing experience (process flows, SOPs, interviewing SMEs, non-conformance and corrective actions)
  • Intermediate experience with MS Office and Visio
  • Demonstrated ability to communicate effectively with Compliance, Legal, Engineering, and Data stakeholders
  • Ability to travel up to 10% to Boston, MA office
  • Experience supporting quality reviews, audits, or regulatory readiness activities
  • Experience working within the life science sector
  • Experience working within a Quality Management System (QMS)

What the Team is Saying

Optum Compensation & Benefits Highlights

  • Leave & Time Off Breadth PTO accrues each pay period with eight paid U.S. holidays plus a floating holiday, and generous time away is consistently emphasized. This breadth supports planned and unplanned time off beyond standard vacation days.
  • Parental & Family Support Six weeks of paid parental leave, up to two weeks of paid caregiver leave, Bright Horizons back‑up care, and adoption assistance signal strong family-oriented support. EAP access with counseling sessions further extends help to employees and their households.
  • Wellbeing & Lifestyle Benefits Company‑paid short‑ and long‑term disability, Calm app membership, tuition reimbursement, commuter and FSA accounts, and broad employee discounts expand everyday wellbeing resources. Free or low‑cost virtual visits complement these lifestyle supports.

Optum Insights

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The Company
HQ: Eden Prairie, MN
160,000 Employees
Year Founded: 2011

What We Do

Optum, part of the UnitedHealth Group family of businesses, is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together. At Optum, we support your well-being with an understanding team, extensive benefits and rewarding opportunities. By joining us, you’ll have the resources to drive system transformation while we help you take care of your future. We recognize the power of connection to drive change, improve efficiency and make a difference in health care. Join a team where your skills and ideas can make an impact and where collaboration is key to creating technology that produces healthier outcomes.

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Optum Offices

Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Optum has three workplace models that balance the needs of the business and the responsibilities of each role. These models, core on‑site (5 days/week), hybrid (4 days/week) and telecommute or fully remote, vary by country, role and location.

Typical time on-site: Not Specified
HQEden Prairie, MN
Metro Manila, Philippines
Cebu, Philippines
Davao, Philippines
Ann Arbor, MI
Atlanta, GA
Baltimore, MD
Bengaluru, India
Chennai, India
Dallas, TX
Detroit, MI
Dublin, Ireland
Hartford, CT
Houston, TX
Hyderabad, India
Jacksonville, FL
Las Vegas, NV
Letterkenny, Ireland
Louisville, KY
Madison, WI
Minneapolis, MN
Nashville, TN
New Delhi, India
Philadelphia, PA
Phoenix, AZ
Pune, India
Raleigh, NC
San Diego, CA
Washington, DC
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