Full-Time

Lead – Integrated Quality Management

Csv

Posted on 12/6/2022

Flatiron Health

Flatiron Health

1,001-5,000 employees

Provides technology for cancer care solutions

Data & Analytics

Senior

Remote + 1 more

Required Skills
Agile
Communications
Management
Requirements
  • 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)
  • 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
Responsibilities
  • 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

At Flatiron Health, the focus on integrating cutting-edge technology with daily patient care in cancer treatment not only drives tangible improvements in outcomes but also provides a dynamic and progressive work environment. Employees at Flatiron Health are at the forefront of transforming oncology care through innovative solutions like Clinical Pipe™ and Flatiron Vessel™, ensuring their work significantly contributes to advancing the field and improving patient lives. This culture of impactful innovation makes Flatiron Health a compelling place for professionals passionate about making a difference in healthcare.

Company Stage

M&A

Total Funding

$2.2B

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

-2%

2 year growth

16%

Benefits

Work/life autonomy via flexible work hours and flexible paid time off

Generous parental leave (16 weeks for either parent)

Transition back to work program following parental leave

Child and caregiver travel benefits for new parents

Backup child care

Weekly meditation sessions

Flatiron-sponsored fitness classes

Weekly massages and manicures available onsite (employee funded)

INACTIVE