Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Quality Assurance Professional to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Are you ready to be the next changemaker in cancer care?
What You'll Do
In this role, you'll work with the Integrated Quality Management (IQM) team and cross-functional research teams to define, maintain, oversee, and optimize the quality management system. You will provide quality partnership across Flatiron Health's business through quality management and quality oversight activities intended to accelerate quality improvement.
This role includes collaborating with key stakeholders to provide guidance on quality matters and leading the key elements of the IQM program against strategic priorities.
In this role you will:

• Implement risk-based Quality Assurance (QA) activities focused on risk assessment; issue identification, escalation, management; corrective/preventive action (CAPA) management, and continuous improvement activities
• Serve as an quality consultant to project teams providing quality advice regarding topics such as: interpretation of applicable regulatory requirements; research best practices; document management; process development/improvement; audit and inspection readiness; and risk management
• Support client audit/regulatory authority inspections, including internal facilitation/oversight of associated readiness and/or post-audit action plans
• Support internal and vendor audit activities, and related follow-up and close-out activities
• Work as an active member of IQM to enhance, implement, and assess the health of Flatiron's quality management system
• Foster a quality culture focused on meeting high quality, ethical and regulatory standards
• Design, implement, and oversee quality training

Who You Are
You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you're a proactive research Quality Assurance professional with at least 4 years of directly applicable experience.

• You have direct experience in a QA role within a contract research organization [CRO], or biopharma company conducting clinical development, or Real World Evidence (RWE)-based research
• You have experience and knowledge in applying Good Clinical Practice (GCP)/Good Pharmacoepidemiology Practices (GPP), and working with teams to facilitate the creation and adoption of processes that support continuous improvement to quality of our products and services
• You have substantial experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• You have experience supporting audits/inspections
• You have a fit-for-purpose approach to quality; ability to translate your quality knowledge and best practices into deliverables with creative quality solutions
• You have the ability to work within and across teams, and manage multiple simultaneous projects
• You have structured communication skills
• You are passionate about our mission to improve healthcare
• You share our commitments to diversity, inclusion, and belonging; You are excited to use your skills to optimize quality in new and innovative ways

Extra credit

• You have direct expertise with Food and Drug Administration (FDA) drug, and/or biologic regulations (e.g., 21 CFR parts 11, 50, 312, 314)
• You have experience with health outcomes or health economic research (e.g. Good Pharmacoepidemiology Practices [GPP]), epidemiology, and/or late-phase clinical trials (e.g., Phase 3B/4)
• You have worked for a health technology company

Life at Flatiron
At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

• Work/life autonomy via flexible work hours and flexible paid time off
• Comprehensive compensation package
• 401(k) contribution to help you reach your retirement planning goals
• Financial health resources including 1:1 financial advice
• Mental well-being tools and services
• Parental benefits and policies including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services
• Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace.
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Job Compensation Range
Salary Range: $97,600.00 - $146,400.00
Preferred Primary Location: NYC Headquarters
The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.