[Please note that this is an office based position at Flatiron's office in New York, NY]

Flatiron Health expects our organization to meet high quality, ethical and compliance standards. We operate in a highly regulated space, with requirements from Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS), Office of National Coordination of Health IT (ONC), and others.

To that end, Flatiron Health’s Integrated Quality Management team is seeking experienced quality management / quality improvement professionals to define, maintain, and oversee the quality management system. This position will provide quality partnerships across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our community oncology and/or academic medical centers initiatives (e.g., electronic health records, billing solutions, practice management offerings). Such support includes collaborating with key stakeholders to provide quality support and lead the implementation of Flatiron’s quality program in line with strategic priorities.

We are looking for professionals with direct experience with oversight and strategy of healthcare quality management/improvement activities including direct experience with thinking about how to create a quality program intended to ensure that software products are safe, effective, and add value to end users (specifically oncology health care providers). Looking for at least 6 years of direct quality management / quality improvement experience.

Responsibilities:

• Provide proactive quality support regarding healthcare best practices, document control, process development/improvement, and risk management. Enhance and implement Flatiron’s quality management system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality system.
• Implement quality management/oversight activities focused on risk assessment, identification, escalation and management. Guide and reconcile any associated corrective and preventive action plans.
• Foster a quality culture focused on meeting high quality, ethical and compliance standards.
• Enhance and implement document control and training plans for Flatiron’s operating procedures.
• Design, implement and oversee compliance training.
• Ensure proactive audits/inspection readiness which may include the following:
  • Oversee external audits/inspections of Flatiron, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans.
  • Plan, facilitate, document and closure of audits of Flatiron vendors.
• Collaborate with our Product Management, Operations, Oncology, Security, Marketing, and Engineering teams to draft, review and maintain procedures.

Requirements:

• Direct experience within a highly regulated environment such as healthcare (e.g. electronic health records, medical oncology practices, health insurance company, government agency, etc.)
• Working knowledge of one or more of the following United States (US) regulatory frameworks:
  • Health & Human Services (HHS) regulations such as HIPAA privacy rule, HIPAA security rule, protections of human subjects, etc.
  • Office of National Coordination of Health IT (ONC) certification
  • Centers for Medicare and Medicaid Services (CMS) regulations such as Meaningful Use (MU), Merit-Based Incentive Payment System (MIPS), Oncology Care Model (OCM), etc.
• Proactive quality support methodology that can translate complex regulatory principles and healthcare norms into best practices for cross-functional teams
• A flexible approach to quality management / quality improvement (e.g. the ability to translate regulatory knowledge and best practices into project deliverables)
• Bachelor’s degree required
• Ability to work within cross-functional teams and manage multiple simultaneous projects
• Structured communication skills
• Passionate about our mission to improve lives by learning from the experience of every cancer patient

Bonus Points:

• Experience in developing an organizational “culture of quality” and defining a quality management system
• Experience drafting, reviewing, implementing, and ensuring compliance with standard operating procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
• Experience interpreting and translating complex regulatory guidance into action (e.g., interpreting legislation to ensure compliance with health care regulations)
• Oncology and/or clinical experience (e.g. nursing or pharmacy) - or experience working with oncologists/clinicians

Flatiron is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, or Veteran status. If you have a disability or special need that requires accommodation, please let us know.