Lead, Computer Systems Validation (CSV)
[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 defined requirements from the US Food and Drug Administration (FDA), Health and Human Services (HHS), Office of National Coordination of Health IT (ONC), as well as other state and federal requirements.
To that end, Flatiron Health’s Integrated Quality Management (IQM) team is seeking an experienced computer systems validation (CSV) professional to define, maintain, and oversee Flatiron’s strategy with regard to adherence to applicable regulatory requirements (e.g., 21 CFR Part 11: Electronic Records; Electronic Signature). This position will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. Such support includes collaborating with key internal and external stakeholders to provide guidance on CSV matters and lead the implementation of key elements of the quality and compliance program against strategic priorities.
- Provide proactive quality support regarding best practices, document management, 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 and engineering tools 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 project management and 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 management 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 requirements for computer systems projects.
- Applicants with at least 4 years of direct experience with completion of day to day validation activities.
- Experience of working within a highly regulated environment (e.g. licensed laboratory, commercial manufacturing, life sciences)
- Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
- A flexible approach to quality; ability to translate and infuse regulatory 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 quality” and risk-based validation activities
- Experience drafting, reviewing, implementing and ensuring compliance with validation procedures that drive efficiency and foster a creative approach to solving business needs
- Ability to work within cross-functional team and manage multiple simultaneous projects
- Structured communication skills
- Passionate about our mission to improve healthcare through technology
- Direct experience as a computer systems validation auditor (e.g. internal audits, vendor audits).
- Experience with contemporary software development (ideally agile software development, cloud applications, machine learning, etc.)
- Managing and driving validation projects to completion working across cross functional teams
- Project Management Professional (PMP) Certification
- 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