Senior Clinical Quality Analyst

UnitedHealth Group; Dallas (TX); Remote; USD 73,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Incentive programs

Equity stock purchase

401k contribution

Job summary

UnitedHealth Group is seeking a Compliance Specialist to lead the development and implementation of accreditation readiness plans across NABP, URAC, and ACHC standards. You will collaborate with Pharmacy Operations, Licensing, Compliance, and Legal to ensure ongoing readiness and readiness for inspections.

The role emphasizes QA/QI project work, training development, and day-to-day management of regulatory documentation within a national remote setup.

Qualifications

• High School Diploma / GED or equivalent.
• Must be 18 years or older.
• 3+ years of healthcare compliance, pharmacy operations, pharmaceutical distribution, or pharmacy fulfillment experience.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Travel may be required up to 25% with a valid driver's license.
• Ability to work full time, Monday - Friday, during 8:00 am - 5:00 pm.

Responsibilities

• Complete NABP applications, inspections documentation, and reaccreditation submissions.
• Develop accreditation plans, timelines, gap analyses, and evidence trackers.
• Collaborate cross-functionally with Operations, Licensing, Compliance, Legal, Quality and leadership for accreditation reviews.
• Identify accreditation/regulatory risks and implement corrective actions.
• Develop training modules for accredited areas.
• Serve as SME for Quality Improvement Projects (QIPs), CAPs and QIAs.
• Review transactions, distribution records, licenses, and training records for inspections.
• Support NABP URAC on-site accreditation surveys and monitoring visits.
• Interpret NABP Drug Distributor criteria and DSCSA requirements for compliance.
• Educate and influence stakeholders to engage in accreditation processes.

Skills

Strong interpersonal skills

Education

High School Diploma / GED

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

This position is National Remote. You'll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.

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.

For those who want to invent the future of health care, here's your opportunity. We're going beyond basic care to health programs integrated across the entire continuum of care. Join us and help people live healthier lives while doing your life's best work.SM

Responsible for ensuring the development and implementation of the annual accreditation preparedness plan that meets or exceeds required compliance with NABP, URAC, and ACHC standards across pharmacy and wholesale locations. Work with Pharmacy Operations, distribution and licensing to develop an ongoing readiness and quality improvement strategy to ensure ongoing compliance.

This position contributes to the departmental objectives of maintaining operational conformance with established quality standards, regulatory, accreditation and contractual requirements, streamlining business processes, and using continuous quality improvement methodologies to identify opportunities for improvement.

This position involves the use of Personal Health Information (PHI).

This position is full time, Monday - Friday. Employees are required to work during our normal business hours of 8:00 am - 5:00 pm.

This will be on the job training and the hours during training will be during normal business hours

Primary Responsibilities:

• Complete and manage NABP applications, Supply Chain Inspection documentation, annual compliance reviews, maintenance attestations, organizational-change notifications, adverse-action reporting, and reaccreditation submissions.
• Develop and manage accreditation plans, timelines, gap analyses, standards-to-evidence trackers, policy assessments, risk logs, dashboards, and other tools supporting ongoing compliance.
• Collaborate cross-functionally with Operations, Licensing, Compliance, Legal, Quality, leadership, and business leads to obtain required information and prepare for accreditation reviews and NABP Supply Chain Inspections, including readiness reviews, mock inspections, operational walkthroughs, staff preparation, and follow-up responses. Be on standby for day of support with unannounced audits.
• Proactively identify accreditation and regulatory risks, communicate barriers, and partner with business stakeholders to develop and implement corrective actions addressing identified gaps and root causes.
• Develop and maintain training modules and staff education for accredited areas.
• Act as Subject Matter Expert (SME) in the development and documentation of Quality Improvement Projects (QIPs), Corrective Action Plans (CAPs) and Quality Improvement Activities (QIAs) for accrediting bodies.
• Review and validate information such as transactions, distribution records, trading-partner documentation, product-tracing information, licenses, policies, training records, and operational evidence selected for inspection or accreditation review including potential sampling.
• Facilitate and attend ACHC or URAC onsite accreditation surveys and any onsite monitoring visits.
• Interpret and operationalize NABP Drug Distributor criteria, communicate updates and their impact, DSCSA requirements, applicable FDA requirements, state wholesale-distributor laws, and other federal or state drug-distribution requirements.
• Educate, motivate, and/or influence others (e.g., leadership, other stakeholders, including those for whom there is no direct line of authority) to engage in and commit to the process.

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:

• High School Diploma / GED
• Must be 18 years OR older
• 3+ years of healthcare compliance, pharmacy operations, pharmaceutical distribution, or pharmacy fulfillment experience
• Proficiency in Microsoft Excel, Microsoft Word, and Microsoft PowerPoint
• May require travel by plane or car, with minimal notice, based on accrediting agency policies. Travel may be required up to 25% of the time and requires a valid driver's license.
• Ability to work full time, Monday - Friday. Employees are required to work during our normal business hours of 8:00 am - 5:00 pm.

Preferred Qualifications:

• Working knowledge of Drug Supply Chain Security Act (DSCSA)
• Project management experience
• Experience collaborating with external clients and stakeholders.
• Experience interpreting federal and state regulatory or accreditation requirements
• Experience with wholesale-distributor, manufacturer, repackager, virtual distributor, or third-party logistics operations

Telecommuting Requirements:

• Ability to keep all company sensitive documents secure (if applicable)
• Required to have a dedicated work area established that is separated from other living areas and provides information privacy.
• Must live in a location that can receive a UnitedHealth Group approved high-speed internet connection or leverage an existing high-speed internet service.

Soft Skills:

• Strong interpersonal skills, including positive assertiveness, professional communication, relationship building, and effective written and verbal communication

*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 $72,800 - $130,000 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 help make the health system work better for everyone. Together, we are shaping the future of healthcare by harnessing technology and innovation to make care simpler to navigate, more affordable and more connected for the people we serve. We are committed to creating an inclusive workplace where everyone feels welcomed, valued, heard and respected, empowering people to bring their authentic selves to work and strengthening our collective impact through diverse talents, backgrounds, experiences and perspectives.

UnitedHealth Group and its affiliated brands are 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 and its affiliated brands are a drug-free workplace. Candidates are required to pass a drug test before beginning employment.