Director, IQM Computer Systems Validation (CSV) - job 2 of 2

About the role:

We are open for this candidate to work out of NYC, SF or remotely. 

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 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 supporting strategic priorities. In this role you will:

• Provide proactive Quality leadership for the Computer System Validation (CSV) team (Platforms Squad) including Quality Assurance (QA), procedural document development, risk assessment, and issue management activities (e.g. CAPA management)
• Participate as an active member of the IQM leadership team supporting IQM department development and impact
• Lead, and support, the Platforms Squad in the planning, development and management of an effective, fit for purpose, risk-based CSV program across applicable systems
• Develop and manage an internal audit program for CSV activities that engages stakeholders, and results in continuous improvement
• Coach, lead and mentor direct reports and build a highly capable team through the attraction, training and development of the necessary skilled professionals
• Ensure proactive audit and inspection readiness. Support external audits/inspections of Flatiron’s data and research businesses by clients and/or regulatory authorities.
• Foster a quality culture focused on meeting high quality, ethical and regulatory standards through stakeholder engagement, program development, formal training, and expert consultative service.
• Design, implement, and Quality training

About you:

You're a proactive Research Quality professional with at least 8 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 and leadership experience in Computer System Validation (CSV), including Part 11 compliance.
• 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 a bachelor’s degree (i.e. BA, BS, or equivalent)
• You have demonstrated team leadership, and staff management and development experience
• You have recognized expertise in federal and state regulations and defined requirements from regulatory bodies such as the US Food and Drug Administration, US Dept. of Health & Human Services, Center for Medicare and Medicaid Services, and/or other relevant bodies such as the International Committee on Harmonization
• You have direct experience within a highly regulated environment (e.g. life science company, contract research organization [CRO], etc.) within healthcare, technology and/or clinical drug development
• 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 direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• You have outstanding communication skills (written and verbal, both formal and informal)
• You have the ability to work within cross-functional team and manage multiple simultaneous projects
• 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

If this sounds like you, you'll fit right in at Flatiron.

Extra Credit:

• You have worked directly with software developers
• You have direct experience with quality standards and/or certifications (e.g., International Organization for Standardization [ISO] 9000)
• You have direct experience with regulatory agency inspections
• You have direct experience with international quality guidelines (e.g., International Council for Harmonization [ICH] Q9, E6)
• 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)