Quality Systems Manager
About The Position
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.
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Benefits
- comprehensive benefits package
- incentive and recognition programs
- equity stock purchase
- 401k contribution
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
