Associate, Research Quality & Compliance - Computer Systems Validation (CSV)

| New York

[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 coupled with defined requirements from the US Food and Drug Administration, Health and Human Services, Center for Medicare and Medicaid Services, and others.

To that end, our Research Quality & Compliance team is seeking experienced computer systems validation (CSV) professionals to define and drive Flatiron’s strategy with regard to adherence to applicable regulatory requirements (e.g. 21 CFR Part 11: Electronic Records; Electronic Signature). These positions will support Flatiron’s research initiatives in their efforts to deliver high quality data and and to ensure compliance. Such support includes collaborating with key internal and external stakeholders to provide guidance on technical compliance matters and lead the implementation of key elements of the quality and compliance program against strategic priorities.

Responsibilities:

  • Provide proactive compliance support regarding best practices, document control, process development/improvement and risk management for computer systems. Enhance and implement Flatiron’s quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality system.
  • Determine the appropriate level of qualification and validation necessary for electronic systems to ensure compliance with relevant regulations and industry guidance documents. Design, implement and oversee risk-based computer systems validation activities (e.g. specifications, testing, qualification, release). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.
  • Provide hands-on support to ensure the completion of computer system validation and the associated documentation (e.g. plans, protocols, reports, memos).
  • Foster a quality culture focused on meeting high quality, ethical and compliance standards.
  • Enhance and implement document control and training plans for a compliant approach to the software development lifecycle (SDLC).
  • Design, implement and oversee compliance training.
  • Ensure proactive audits/inspection readiness. Oversee external audits/inspections of Flatiron’s data and research businesses, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans. Plan, complete, document and closure audits of Flatiron vendors.
  • Collaborate with our Product Management, Quantitative Science, Abstraction, Oncology, Security and Software Engineering teams to advise on the correct application of internal and external regulations for computer systems projects.

Requirements:

  • Applicants with direct experience with completion of day to day validation activities (e.g. writing, reviewing and executing test plans/scripts). Looking for at least 2 years of experience.
  • Experience of working within a highly regulated environment (e.g. licensed laboratory, commercial manufacturing, life sciences)
  • Bachelor’s degree required
  • Proactive compliance support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
  • A flexible approach to compliance; ability to translate and infuse compliance knowledge and best practices for computer systems validation
  • Strong working knowledge of regulations for electronic systems validation (specifically 21 CFR Part 11).
  • Experience in developing an organizational “culture of compliance” and risk-based validation activities.
  • Experience drafting, reviewing, implementing and ensuring compliance with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
  • Ability to work within cross-functional team and manage multiple simultaneous projects
  • Intellectually curious, with outstanding problem-solving skills
  • Nose for value; able to effectively prioritize in a challenging, time-sensitive environment
  • Impeccable communication skills
  • Passionate about our mission to improve healthcare through technology

Ideal Experience:

  • Direct experience as a computer systems validation auditor (e.g. internal audits, vendor audits).
  • Experience with agile software development (ideally SCRUM methodology)

Bonus Points:

  • Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 314, 812, 814) or Good Clinical Practice (GCP)
  • Understanding of the global regulatory landscape (e.g. European regulations such as annex 11) and ability to apply global best practices to daily tasks
  • Oncology and/or clinical experience (e.g. nursing degree)
  • Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
  • Experience with designing protocols, case report forms, regulatory submissions, etc.
  • You’ve worked at a technology partner to a life sciences company
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

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

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

Perks of working here

401(K)
Casual Dress
Child Care
Commuter Benefits
Company Equity
Company Outings
Conferences & Training
Daily Meals Provided
Dental
Flex Work Hours
Happy Hours
Health Benefits
Generous Parental Leave
Stocked Kitchen
Vision
Volunteering Opportunities
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