Lead/Manager, Healthcare Quality Assurance

| Greater NYC Area

[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.

Responsibilities:

  • 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.

Requirements:

  • 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

Bonus Points:

  • 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
Read Full Job Description

Technology we use

  • Engineering
    • .NETLanguages
    • C#Languages
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • jQueryLibraries
    • ReactLibraries
    • AngularJSFrameworks
    • ASP.NETFrameworks
    • Node.jsFrameworks
    • Microsoft SQL ServerDatabases
    • PostgreSQLDatabases

Location

Flatiron Health is in the heart of the Flatiron District. Eataly is right downstairs and we oversee Madison Square Park.
200 5th Avenue, New York, NY 10010

Insider's spotlight

What’s the vibe like in the office?

The most exciting part of being in my company is solving a real problem at scale through serious collaboration. Oncologists, software engineers, statisticians, business folks, etc. all have to come to the table together, as equals, to figure this one out. And we are doing it.

Amy

Chief medical Officer

What kinds of technical challenges do you and your team face?

An engineer and oncologist work together over several weeks to build an algorithm from a naive prototype to a highly specialized and flexible rule set that can accurately represent the lines of therapy for 95% of patients within a specific disease subset.

Abhishek

Software Engineer

How does the company support your career growth?

As engineering manager, I am invested in the professional development of the people I work with. I train team members by pulling them out of their comfort zones to the uncomfortable territory. At Flatiron, it is one of our values - greatness and comfort rarely co-exist.

Kevin

Software Engineering

What is your vision for the company?

At Flatiron, we believe that learning from the experience of every cancer patient is an imperative — it is the key to accelerating research and continuing to improve the quality of care. Our mission is to serve cancer patients and our customers by dramatically improving treatment and accelerating research.

Zach Weinberg

Co-Founder, President and COO

What's the biggest problem your team is solving?

Instead of studying the cells, I now have the opportunity to write about the patients. I can tell their stories through the research lens and enable them to advance clinical cancer research through their experiences. I certainly never lose sight of the human behind the cell anymore.

Rana

Medical Writer

What are Flatiron Health Perks + Benefits

Health Insurance & Wellness Benefits
Dental Benefits
Vision Benefits
Health Insurance Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Child Care
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Paid Volunteer Time
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Daily Meals Provided
Stocked Kitchen
Happy Hours
Professional Development Benefits
Job Training & Conferences

Additional Perks + Benefits

Flatiron’s holistic employee experience program translates our values into reality.
We cater to the well being of our employees both mentally and physically to promote a culture where wellness is at the forefront. By managing weekly mental wellness programs, monthly office wide fun and fitness classes, we give employees the opportunity to directly incorporate a mindful balance into their day to day life.

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