Lead/Manager, Healthcare Quality Assurance
[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 simultaneous federal and state regulations from the US Food and Drug Administration (FDA), Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS), and others.
To that end, Flatiron Health is seeking experienced quality assurance (QA) professionals to define, maintain and oversee Flatiron’s quality system. Based on training and experience, this position will support quality commitments across Flatiron’s healthcare initiatives in their efforts to deliver high quality products and to ensure regulatory compliance. This may include quality partnership and oversight of activities focused on community oncology (e.g., electronic health records [EHRs], insurance billing), research (e.g., human subject protection), and/or academic medical centers (e.g. scientific publications). Such support includes collaborating with key stakeholders to provide regulatory guidance and lead the implementation of Flatiron’s quality program in line with strategic priorities.
We are looking for professionals at various levels as follows:
Coordinator: Applicants with experience with completion of day to day healthcare quality assurance activities (e.g., data review, project tracking). Looking for at least 2 years of experience.
Lead: Applicants with direct experience with completion of day to day healthcare quality assurance activities (e.g. quality monitoring/auditing, project support, implementing changes in regulations). Looking for at least 4 years of direct experience.
Manager: Applicants with direct experience with oversight and strategy of healthcare quality assurance activities. Direct experience with thinking about how to create a compliance program. Looking for at least 6 years of direct experience.
- Provide proactive quality support regarding healthcare best practices, document control, process development/improvement and risk management. Enhance and implement Flatiron’s quality 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 audits of Flatiron vendors.
>Collaborate with our Product Management, Operations, Oncology, Security and Engineering teams to draft, review and maintain procedures.
- Direct experience within a highly regulated environment (e.g. EHRs, life science company, Accountable Care Organization [ACO], oncology practice, health insurance company, government agency, etc.) preferably within healthcare and/or research
- 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.
>Food and Drug Administration (FDA) regulations such investigational new drugs, biologics, devices, etc.
- Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional teams
- A flexible approach to quality (e.g. the ability to translate regulatory knowledge and best practices into project deliverables)
- Bachelor’s degree required
- Ability to work within cross-functional team and manage multiple simultaneous projects
- Structured communication skills
- Passionate about our mission to improve healthcare through technology
- Experience in developing an organizational “culture of quality” and defining a quality 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)
- Experience conducting clinical trials at a clinical research site and/or experience as a study coordinator, monitor (i.e. Clinical Research Associate), project manager
- Understanding of the global regulatory landscape (e.g. European regulations) and ability to apply global best practices to daily tasks
- Oncology experience
- Clinical experience (e.g. nursing degree)
- Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications