Associate Manager / Lead, Quality Management [GCP / Validation Focused] at Flatiron Health

| Greater NYC Area
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We're looking for a Quality Professional to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team, and why Flatiron Health is the right next step in your career. 

What You'll Do

In this role, you'll work with the Integrated Quality Management 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 includes support for our research initiatives (e.g., human subjects protection), partnerships with academic medical centers (e.g., scientific publications), and/or software development lifecycle (e.g., risk-based validation). 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:

  • Provide proactive quality support regarding research best practices, document management (including quality assurance [QA] and quality control [QC] checks), process development/improvement, and risk management
  • Implement risk-based quality management activities focused on risk assessment, identification, escalation, and management 
  • 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
  • Design, implement, and oversee quality training

Who You Are

You're a proactive Research Quality professional with at least 4 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 have direct subject matter expertise in at least one of the following disciplines:  Good Clinical Practice (GCP), Good Pharmacoepidemiology Practices (GPP), Computer System Validation (CSV)
  • You have direct expertise with Food and Drug Administration (FDA) drug, device, and/or biologic regulations (e.g., 21 CFR parts 11, 50, 312, 314, 812, 814, 820)
  • 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 a flexible 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
  • 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)If this sounds like you, you'll fit right in at Flatiron. 

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 direct experience with international quality guidelines (e.g., International Council for Harmonization [ICH] Q9: Quality Risk Management)
  • You have direct experience with international research regulations (e.g., European Union Clinical Trial Directive)
  • You have worked for a technology company (or have worked directly with software developers)
  • You have experience with health outcomes and economic research, epidemiology, and/or late-phase clinical trials (e.g., Phase 3B/4)
  • You have oncology and/or clinical experience

Why You Should Join Our Team

A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.

At Flatiron, we strive to build and maintain an environment where employees from all backgrounds are valued, respected and have the opportunity to succeed. You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer: 

  • Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages, and more
  • Career coaching opportunities
  • Hackathons for all employees (not just our engineers!)
  • Professional development benefit for attending conferences, industry events, and external courses
  • Work/life autonomy via flexible work hours and flexible paid time off
  • Generous parental leave (16 weeks for either parent)
  • Back-up child care
  • Flatiron-sponsored fitness classes

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.

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Technology we use

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

Location

Our office at One Soho is easily accessible and modern, and has all the amenities our employees need to be comfortable, productive and collaborative.

An Insider's view of Flatiron Health

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 Engineer

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

Flatiron Health Benefits Overview

Flatiron has a holistic approach to employee experience. We promote a culture with wellness at the forefront.

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Documented equal pay policy
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Family Medical Leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Stocked Kitchen
Some Meals Provided
Happy Hours
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Promote from within
Mentorship program
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