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 Professional  to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?

What You’ll Do

In this role, you’ll work as part of the Integrated Quality Management (IQM) team and with cross-functional research teams to define, maintain, oversee, and optimize the quality management system. You will provide quality partnership across Flatiron Health’s Evidence business through quality management and quality oversight activities intended to accelerate quality improvement. 

This includes support for our product development, and research initiatives and the associated software development lifecycle, focusing on Computer Systems Validation (CSV) of internally developed, and externally sourced applications. Such support includes collaborating with key stakeholders to provide guidance on quality matters and lead the implementation of key elements of the quality program against strategic priorities. In addition, you’ll also:

• Drive risk-based, fit-for-purpose Computer Systems Validation activities focused on risk assessment, and downstream planning and deliverables (including document creation and system testing). 
• Partner with cross-functional development groups that follow an Agile development methodology and provide guidance on CSV process and 21 CFR Part 11 regulation
• Provide proactive quality support regarding research best practices, document management (including documentation of quality assurance and quality control checks), process development/improvement, and risk management
• Skilled in issue management and corrective/preventive action (CAPA) management 
• Ensure proactive audits/inspection readiness. Support external audits/inspections, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans
• 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
• Create, implement, and deliver 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 professional with at least 2 years of experience. You’re excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate, and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact. You’re excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. 

• You have direct subject matter expertise and experience in leading end-to end Computer System Validation projects that leverage an Agile methodology and automated testing.
• You have direct expertise with Food and Drug Administration (FDA) drug, device, and/or biologic regulations (e.g. 21 CFR Parts 11, 312, 314)
• You have direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or research
• You have direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs) as well as the associated training plans
• You have experience with industry best practices (e.g., Good Automated Manufacturing Practices [GAMP] 5)
• You have a fit-for-purpose approach to quality; ability to translate/infuse quality knowledge and best practices into research deliverables with creative quality solutions
• You have the ability to work within cross-functional team and manage multiple simultaneous projects
• You have structured communication skills (verbal and written)
• You are a critical thinker and are able to see the big picture, plan ahead, and put thought into action
• You are passionate about our mission to improve healthcare through technology
• You share our commitments to diversity, inclusion, and belonging; You are excited to use your skills to optimize quality in new and innovative ways
• You live in the NYC area (or are open to relocating to the NYC area)

Extra credit

• You have direct experience with quality standards and/or certifications (e.g., International Organization for Standardization [ISO] 9000)
• You have direct experience with process improvement methodologies (e.g., Lean Six Sigma training and/or certification)
• You have worked for a technology company (or have worked directly with software developers

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 paid 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.