Senior Manager, Quality Management Systems [FDA / Research Focused] at Flatiron Health
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 will lead Flatiron’s efforts to define, maintain, oversee, and optimize our quality management system (QMS) in coordination with the Integrated Quality Management (IQM) team and leadership. IQM’s mission is to provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement.
Secondly, you will support our research initiatives (e.g., human subjects protection, good clinical practice [GCP], computer systems validation, academic partnerships). Such support includes collaborating with key stakeholders to provide guidance on quality matters and lead the implementation of key elements of the QMS against strategic priorities. While this role is primarily focused on Flatiron’s research QMS (e.g., real-world evidence), you may also support quality efforts across our business (e.g., electronic health records).
In addition, you'll also:
- Conduct and enhance the ongoing assessment of the QMS; Summarize and present the assessment for leadership; Identify, implement, and oversee strategic investments to continuously improve the QMS
- Identify and steer process improvements across the organization intended to define, implement, and enhance fit-to-purpose research foundations based on regulatory requirements, industry best practices, and internal quality commitments
- Identify and steer process improvements across the quality team including but not limited to our approach to proactive quality support focused on research best practices, good documentation practices, quality by design, process improvement, etc.
- Implement risk management activities focused on risk assessment, identification, evaluation, escalation, management, and closure; Identify trends to guide process improvement projects
- Foster and enhance an organizational culture of quality focused on meeting high quality, ethical, and regulatory standards
- Ensure proactive audits and inspection readiness; Support external audits/inspections, including liaising with clients/regulators, hosting on-site visits, and guide internal teams with the associated action plans; Conduct internal audits
- Provide proactive quality support that pairs complex regulatory requirements with business goals for cross-functional research teams
- Design, implement, and oversee quality/regulatory trainings
Who You Are
You're a proactive Research Quality professional with at least 8 years of experience with activities to support and oversee a research quality management system fit for the life science space. 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 experience in developing, assessing, and optimizing a QMS within highly regulated healthcare and/or research environments (e.g. life science company, contract research organization [CRO], contract manufacturing organization [CMO], etc.)
- You have direct subject matter expertise in at least one of the following disciplines: Good Clinical Practice (GCP), Good Pharmacoepidemiology Practices (GPP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Validation Practices, and/or Good Pharmacovigilance Practices (GVP)
- 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 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 that can be tailored to leadership and project teams
- 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); Candidates outside of NYC may be considered provided that they can periodically travel to the NYC office (pending pandemic related health/safety precautions)
If this sounds like you, you'll fit right in at Flatiron.
- 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.