Flatiron Health
Reimagining the infrastructure of cancer care.
New York, NY

Manager, Healthcare Quality Assurance

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[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 the Food and Drug Administration (FDA), Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS), and others.

To that end, Flatiron Health’s Integrated Quality Management (IQM) team is seeking experienced quality assurance (QA) professionals to define, maintain, and oversee the quality system. This position will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our community oncology (e.g., electronic health records [EHRs], insurance billing), research (e.g., human subjects protection), and/or academic medical centers (e.g., scientific publications) initiatives. 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 with direct experience with oversight and strategy of healthcare quality assurance activities including direct experience with thinking about how to create a compliance program. Looking for at least 6 years of direct quality/compliance 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
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What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

At Flatiron, we are committed to providing our employees with the resources they need, both within and outside of work. This enables them to concentrate their working hours on improving cancer care and accelerating cancer research, while dedicating their non-working hours to everything else life has to offer.

We offer a full range of benefits to support our employees and their families. These benefits include health and wellness, family planning, financial planning and time away.

Culture
Volunteer in local community
Partners with nonprofits
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Hybrid work model
Employee awards
Flexible work schedule
Remote work program
Diversity
Documented equal pay policy
Dedicated diversity and inclusion staff
Mandated unconscious bias training
Diversity manifesto
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
401(K) matching
Company equity
Performance bonus
Pay transparency
Child Care & Parental Leave Benefits
Childcare benefits
Generous parental leave
Family medical leave
Adoption Assistance
Return-to-work program post parental leave
Company sponsored family events
Fertility benefits
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
Paid holidays
Paid sick days
Flexible time off
Company-wide vacation
Office Perks
Commuter benefits
Free snacks and drinks
Some meals provided
Relocation assistance
Meditation space
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Customized development tracks
Personal development training
Apprenticeship programs

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