Quality Systems Manager

Quality Systems Manager

Optum 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.

The Quality Systems Manager will be responsible for the hands-on execution and maintenance of the Quality Management System (QMS) supporting Optum Frontier Therapies specialty pharmacy and specialty distribution operations, with a focus on rare and ultrarare, high-risk therapies. Reporting to the Las Vegas Site Director, this role will serve as the operational quality lead, driving systematic data collection, monitoring, documentation, and evaluation of pharmacy and distribution services. Based on findings and trends, the Quality Systems Manager will implement improvement initiatives and collaborate closely with cross-functional partners across the organization. This is an individual contributor ('working manager') role with no direct reports. The Quality Systems Manager is expected to personally execute core quality activities and influence outcomes through strong cross functional partnership within a matrixed organization.

This position follows a hybrid schedule with Three in-office days per week. Location: 6425 Santa Margarita, Unit 110, Las Vegas, NV 89118 Hours: Monday - Friday 8:00 AM - 4:30 PM

Primary Responsibilities

• Execute and maintain the OFT Quality Management System, including required quality records, logs, dashboards, and documentation
• Ensure QMS activities align with internal procedures, accreditation standards, and applicable regulatory requirements

Incident, Complaint & CAPA Management

• Manage intake, investigation, documentation, and trending of quality related events, including medication errors, near misses, distribution incidents, adverse events, and complaints
• Analyze incidents and complaints to identify root causes and implement corrective actions
• Develop, document, and track corrective and preventive actions (CAPAs) through completion, including effectiveness checks
• Escalate significant or high-risk quality issues to leadership in accordance with policy

Regulatory, Accreditation & Audit Readiness

• Serve as a primary operational quality contact during internal, regulatory, accreditation, manufacturer, payer, and vendor audits
• Support virtual audits from internal, regulatory, payer, and vendor partners
• Coordinate mock audits, gap assessments, documentation reviews, and preparation of audit evidence
• Prepare written responses and CAPA plans related to audit findings or observations

REMS, Manufacturer & Limited Distribution Drug (LDD) Support

• Partner with REMS administrators to ensure REMS compliance and conduct routine internal audits
• Support quality requirements associated with REMS programs, limited distribution drug (LDD) networks, and manufacturer specific programs
• Ensure documentation, training, monitoring, and reporting requirements tied to manufacturer agreements and REMS programs are met and audit ready

Policies, Procedures & Training Support

• Collaborate with site Pharmacists in Charge and Designated Representatives to maintain current and applicable policies and procedures
• Maintain and review quality related SOPs, policies, and work instructions to ensure accuracy and regulatory alignment
• Work with training, operations, and client strategy teams to ensure training programs are timely, relevant, and properly documented
• Verify documentation of required onboarding and annual quality/compliance training

Performance Improvement & Quality Reporting

• Develop performance metrics aligned with business objectives
• Conduct program reviews with stakeholders to identify opportunities for continuous improvement
• Track, analyze, and trend quality metrics related to patient safety, compliance, and service performance
• Support preparation of quality summaries and reports for leadership, manufacturers, and accrediting bodies

Cross Functional Collaboration

• Collaborate with Pharmacy Practice to develop and implement quality processes
• Align with Optum's Pharmacy Quality Control & Assurance team to support enterprise-wide quality initiatives
• Navigate a matrixed organization using strong relationship building and clear communication skills
• Work with senior leadership to resolve issues impacting pharmacy or distribution compliance
• Support new product launches, program expansions, and operational changes from a quality and compliance perspective

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:

• Bachelor's degree in a relevant field
• 3+ years of experience in Quality Assurance or a related field or experience
• Solid understanding of FDA, DEA, State Boards of Pharmacy, USP, and other regulations related to drug manufacturing, dispensing, and distribution
• Willingness to travel as needed to support quality related activities (~10%)

Preferred Qualifications:

• Degree in Business Administration or related field
• Applicable quality or compliance certification (e.g., CPHQ, Lean, Six Sigma)
• Experience in quality oversight of specialty pharmacy operations, including rare or ultra-rare disease therapies
• Familiarity with accreditation standards such as URAC, ACHC, NABP, and USP
• Experience with pharmacy/wholesale accreditation
• Solid verbal and written communication skills
• Effective problem-solving abilities
• Experience working in a matrixed environment

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.

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.