Quality Systems Manager

UnitedHealth Group•Las Vegas, NV

1d•Hybrid

About The Position

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

Requirements

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%25)

Nice To Haves

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

Responsibilities

Quality Management System (QMS) Execution
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