Lead – Regulatory Compliance Operations
Clinical Research
Posted on 3/29/2023
Flatiron Health

1,001-5,000 employees

Improving healthcare by learning from the experience of cancer patients
Company Overview
Flatiron seeks to identify and solve problems that drive work that moves the needle for customers and patients. In short, they seek to learn and improve cancer research from each patient.
Salt Lake City, UT, USA
Experience Level
Desired Skills
Google Cloud Platform
DevOps & Infrastructure
  • You have a B.A. or B.S. (preferred degree in scientific discipline)
  • You have direct knowledge and experience in a GxP environment with focus on GCP, FDA, and ALCOA+
  • You have knowledge and experience with data privacy and security frameworks such as HIPAA, GDPR, NIST, CSF
  • 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 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 have experience working within a matrixed environment, and in hybrid work environment
  • You have direct experience with software defect, bug reporting and escalation in Agile development releases; proficiency in systems for detecting tracking (e.g. JIRA, BitBucket); experience with enterprise SaaS products running in AWS
  • You have experience with GAMP5
  • You have direct experience with process improvement methodologies
  • You have worked for a technology company (or have worked directly with software developers)
  • Provide in-process support to CRBU software engineering teams throughout the lifecycle (SDLC) to support compliance with FDA, EMA, MHRA, and ICH requirements including 21 CFR Parts 820, 312, 11; Annex 11, ICH GCP E6R2
  • Support activities that maintain SOC2 certification. Partner with Security to support SOC2 audit activities
  • Help develop, standardize, and continuously improve applicable processes and procedures across the CRBU programs as well as implement new initiatives with the rapidly growing team
  • Support issue escalation, management, and improvement plans
  • Ensure proactive client audit/regulatory authority inspection readiness. Support external audits/inspections as a Subject Matter Expert (SME), including coordinating responses and internal oversight of associated action plans (e.g. CAPAs). Support internal audit activities
  • Support potential and existing client interactions/requests for information
  • Support team with communication and escalation of related risks and issues as required
  • Support initiatives to select and oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and Oversight Plans
  • Lead creation, review and revision of departmental SOPs, and related documents
  • Works closely with Integrated Quality Management (IQM) to support client audits, Computer Systems Validation (CSV) activities, internal audit program, and other QMS related activities
  • Support and ensure department compliance with Legal, Privacy & Compliance (LP&C) teams, and Security processes and programs
  • Provide proactive support regarding research best practices, document management (including quality control [QC] checks), process development/improvement, change control, and risk management