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Job Details


UnitedHealth Group

Senior Director, Quality and Regulatory - Telecommute (16401281)

Healthcare

All

Yearly

Full Time

No

Minneapolis, Minnesota, United States

Optum Labs is the research and development arm of UnitedHealth Group. We're a diverse team of curious thinkers and experts in big data, artificial intelligence and machine learning, and scientific and clinical research searching for new ways to help people live healthier lives. We partner with world leaders in health care delivery, research, and technology to create disruptive solutions that serve patients, caregivers, providers, and commercial and government payers.

More equitable, effective, and affordable health care - that's our goal. We aren't just trying to improve the care an individual receives. We're building a future where the health care system works better for everyone. Make yourself at home with us and start doing your life’s best work.(sm)

Optum Labs is seeking a dynamic and passionate Senior Director, Quality and Regulatory to develop and own processes and systems for quality assurance, quality control, and the quality management systems that are fit for purpose: clinical or market testing and scaling of innovative high impact health care solutions that improve clinical outcomes, lower total cost of care, and improve the patient, provider, enterprise business partner, or client experience.

The Senior Director, Quality and Regulatory will partner with centers of excellence in UnitedHealth Group enterprise functions (Optum Center for Research and Innovation, Office of Human Research Subject Protection, Regulatory Affairs, and the research program teams in Optum Labs) to institute and drive a robust quality program focused on ensuring compliance and quality standards are met across the portfolio of Research & Clinical projects in Optum Labs. Innovate to simplify is a core leadership principle of Optum Labs, and the successful individual will enable high research quality and compliance with simple, and “fit for purpose” processes and systems.

You’ll enjoy the flexibility to telecommute* from anywhere within the U.S. with sufficient broadband connectivity and proximity to an airport with daily commercial flights. Alternatively, you may be office based in a major Optum Labs campus in Minneapolis/Minnetonka, MN; Seattle, WA; or New York, NY.

Primary Responsibilities:
  • Assess quality and regulatory systematic needs across Optum Labs portfolio and organization, leveraging what systems and resources exist within UnitedHealth Group and working collaboratively to scale best practices and frameworks
  • Embody a shared accountability for data quality and integrity in individual research projects
  • Develop and seek leadership endorsement for a quality and regulatory set up, inclusive of:
    • Quality Management (QM) / QM Systems (QMS):
      • Create a robust Quality Management System that complies with regulatory, industry, and internal quality standards
      • Assess the need for, develop and implement procedures and procedural documents
      • Develop role-based training and credentialing requirements for research staff; develop an effective knowledge management framework
      • Develop an overall process map and RACI, and framework for process ownership
      • Embed a strong quality culture within Optum Labs through cross-functional collaborations and clear processes for issue escalation
    • Quality Assurance (QA):
      • Drive and deliver audit strategies and capabilities in line with the R&D portfolio and regulatory requirements
      • Develop operational audit plans and oversee the execution of the internal/external audit portfolio
      • Oversee and partner with proper functions in the investigation of suspected deviations, preventative and corrective action planning, and follow-through
    • Quality Control (QC):
      • Drive quality metric threshold setting, quality surveillance and reporting to leadership via appropriate governance forums
      • Initiate corrective and preventative action plans in response to broader trends
    • Quality Planning/Support:
      • Develop the quality support model for end-to-end support for individual research scientific and operations teams.
      • For programs that develop solutions considered a “Software as a Medical Device” (SaMD), the individual is accountable for guiding R&D teams on quality and regulatory requirements, building a robust quality management plan, and ensuring regulatory inspection readiness
  • Lead change management for new or changed ways of working across Optum Labs, in accordance with the recommended Quality and Regulatory set-up
  • Oversee adherence to quality requirements across the Optum Labs portfolio
  • Develop resourcing strategy; supervise quality and compliance specialists, as needed depending on portfolio requirements
  • Travel: Up to 25% within the US, and outside the US if assigned to an international project

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 preferably in Life Sciences such as Biology, Chemistry, Nursing, etc.
  • 15+ years of experience in the field of medical device and/or pharmaceutical/biotechnology clinical R&D
  • 5+ years of experience in a quality or regulatory function that is business partner to multidisciplinary R&D teams
  • Experience with working with medical device regulations, especially software as a medical device (SaMD). Demonstrated ability to translate these rapidly evolving regulations and standards into quality management systems
  • Experience applying clinical research regulations and standards, such as ICH GCP, and ability to translate these guidelines into quality management systems
  • Full COVID-19 vaccination is an essential job function of this role. Candidates located in states that mandate COVID-19 booster doses must also comply with those state requirements. UnitedHealth Group will adhere to all federal, state and local regulations as well as all client requirements and will obtain necessary proof of vaccination, and boosters when applicable, prior to employment to ensure compliance. Candidates must be able to perform all essential job functions with or without reasonable accommodation

Preferred Qualifications:

  • Experience leading a Quality Management Systems function in a medical software, medical device, or pharmaceutical company
  • Excellent written and oral communication skills
  • Comfort with ambiguity, can effectively cope with change and pivot as necessary
  • Comfort working on decentralized project teams and collaborating on virtual platforms such as Microsoft Teams

To protect the health and safety of our workforce, patients and communities we serve, UnitedHealth Group and its affiliate companies require all employees to disclose COVID-19 vaccination status prior to beginning employment. In addition, some roles and locations require full COVID-19 vaccination, including boosters, as an essential job function. UnitedHealth Group adheres to all federal, state and local COVID-19 vaccination regulations as well as all client COVID-19 vaccination requirements and will obtain the necessary information from candidates prior to employment to ensure compliance. Candidates must be able to perform all essential job functions with or without reasonable accommodation. Failure to meet the vaccination requirement may result in rescission of an employment offer or termination of employment.

We Lead with Diversity, Inclusion and Compassion

At Optum Labs, we are dedicated to building teams where every individual is recognized for their unique experience and contributions. Our Leadership Principles underscore our commitment to inclusion, encouraging us to “walk in each other’s shoes” and open doors for our peers.

UnitedHealth Group supports local, regional, and national organizations that share these values through joint initiatives, event and program participation, volunteerism and giving. Through our Connected Communities, employees can connect with others who have similar – or different – life experiences and backgrounds. These groups are led by peers, supported by Human Capital, and championed by leaders.

We Invest in Talent

Managers at every level are committed to their roles as talent stewards who help guide and nurture professional development. We want our employees to reach their highest level of potential just as they help us reach ours.

At Optum Labs, employees are our first customers. That’s why we offer virtual work environments – to provide work/life flexibility via telecommuting. While it can be a struggle to be a telecommuter, it can also provide enormous benefits for your personal and professional life.

Careers at UnitedHealth Group. We have modest goals: Improve the lives of others. Change the landscape of health care forever. Leave the world a better place than we found it. Such aspirations tend to attract a certain type of person. Crazy talented. Compassionate. Driven. To these select few, we offer the global reach, resources and can-do culture of a Fortune 5 company. We provide an environment where you're empowered to be your best. We encourage you to take risks. And we offer a world of rewards and benefits for performance. We believe the most important is the opportunity to do your life's best work.(sm)

*All Telecommuters will be required to adhere to UnitedHealth Group’s Telecommuter Policy.

Colorado, Connecticut or Nevada Residents Only: The salary range for Colorado/Connecticut/Nevada residents is $134,200 to $257,700. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, UnitedHealth Group offers 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 UnitedHealth Group, you'll find a far-reaching choice of benefits and incentives.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.