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Lead, Computer Systems Validation

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Company :
Flatiron Health

Location :
New York City, New York

Expiry Date :
Tue, 15 Dec 2020 23:59:59 GMT

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Description :
NYC 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 and cross-functional research teams to define, maintain, oversee, and optimize the quality management system. You will provide quality partnership across Flatiron Healths business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our research initiatives and the associated 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 against strategic priorities. In addition, you’ll also: Provide proactive quality support regarding research best practices, document management (including quality assurance [QA] and quality control [QC] checks), process development/improvement, and risk management Implement risk-based computer systems validation activities focused on risk assessment, identification, escalation, and management 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 Flatirons quality management system Foster a quality culture focused on meeting high quality, ethical and regulatory standards Design, implement, and oversee quality training Who You Are You’re a proactive Research Quality professional with at least 4 years of experience. You’re excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. Youre 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 Computer System Validation (CSV) subject matter expertise 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 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 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) If this sounds like you, you’ll fit right in at Flatiron. Extra Credit 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 (Good Pharmacoepidemiology Practices [GPP]), 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 researchall 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 livesat 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.