Research Quality Assurance Manager at Flatiron Health
We're looking for a Research 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. In addition, you'll also:
- Provide proactive quality support regarding research best practices, document control (including quality assurance (QA) and quality control (QC) checks), process development/improvement, and risk management
- Implement risk-based quality management activities focused on risk assessment, identification, escalation, and management
- Issue management and corrective/preventive action (CAPA) management
- 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
- 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
- Enhance and implement document control and training plans for research procedures in collaboration with internal teams
- Design, implement, and oversee quality training
This includes support for our research initiatives (e.g., human subjects protection) and partnerships with academic medical centers (e.g., scientific publications). 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.
Who You Are
You're a proactive Research Quality Manager with at least 6 years of experience with oversight and strategy of research quality activities. 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 experience in developing an organizational “culture of quality” and defining a quality management system
- 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 working knowledge of US FDA drug and/or biologic regulations. Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 812) and electronic data (e.g. 21 CFR Part 11)
- You follow a proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
- You have experience drafting, reviewing, implementing and ensuring quality with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
- You have a flexible approach to quality; ability to translate and infuse quality knowledge and best practices into research deliverables
- 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
If this sounds like you, you'll fit right in at Flatiron.
- You have clinical trials and/or clinical research experience, such as oversight of multi-center clinical research activities including participant screening and recruitment, oversight of clinical research organization and/or vendors supporting research
- You have experience conducting clinical trials at a clinical research site and/or experience as a study coordinator, monitor (i.e. Clinical Research Associate), project manager
- You have oncology and/or clinical experience
- You have scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
- You have experience with designing protocols, case report forms, regulatory submissions, etc.
- You have experience with late-phase research such as phase 3B/4 trials
- You have experience with health outcomes and economic research
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 research—all 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 lives—at 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.