We’re looking for a Head of Integrated Quality Management 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.
Reporting to the Chief Medical Officer, this role is a unique opportunity to lead Flatiron Health’s Quality organization as well as collaborate with cross-functional leaders in support of a quality by design culture.
In this position, you will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities.
What you’ll do:
You will lead the Integrated Quality Management team in the development and execution of strategy across GxP Quality Assurance programs across Flatiron’s software and research products and services. You will be responsible for strengthening, further developing and executing the quality assurance program and management systems in support of Flatiron programs. Such support requires collaborating with key product, regional, and functional stakeholders in the implementation and oversight of an established quality management framework designed to support Flatiron’s business objectives. You will also:
- Ensure company Quality Management System meets standards expected by US and global regulatory authorities for research and development activities.
- Support the writing, review and revision of SOPs to applicable global regulations.
- Provide proactive quality support regarding healthcare best practices, process development/improvement, change management, and risk management.
- Collaborate with cross functional teams across Flatiron to develop and maintain quality policies and procedures around all research and patient safety activities.
- Ensure proactive audit and inspection readiness and oversee all external audits of Flatiron’s data and research businesses, including liaising with clients, conducting on-site visits, and internal oversight of resulting action plans.
- Serve as a champion for continuous improvement in all aspects of total quality management through a well-trained team, streamlined business processes, and appropriate structured quality operations.
- Conduct regularly scheduled risk assessments of research-related compliance and privacy programs and systems.
- Counsel, train and interpret quality requirements to ensure we and our vendors maintain a state of compliance.
- Coach, lead, and mentor direct reports and build a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
- Implement risk-based quality management activities focused on risk assessment, identification, escalation, and management
- Guide teams in the implementation and management of effective corrective and preventive actions to ensure systems and processes are contemporary with current regulatory requirements
- Foster a quality culture focused on meeting high quality, ethical and regulatory standards
- Oversee the quality system and key metrics, of quality activities (e.g. document management, vendor compliance management, CAPAs, internal audits, etc.) to ensure it continuously meets regulatory and business requirements
- Oversee the escalation, management, and timely resolution of critical quality issues that may impact the business
- Serve as trusted Subject Matter Expert to senior leadership on global regulations.
- In collaboration with key stakeholders provide both strategic and tactical Quality input and decisions related to innovative technologies, industry best practices, and new regulations
Who you are:
You're a Research Quality professional and proven leader with at least 15 years of experience. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day, with a forward-looking mentality as it relates to the development of an innovative quality strategy fit for purpose within the emerging complex arena of healthcare technology, data science, and real world clinical research. 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 at least eight years of directly relevant quality experience in the highly regulated environment of the biopharmaceutical and/or pharmaceutical services or health tech industries, and at least 15 years of quality experience overall in regulated industries.
- You have a bachelor’s degree (i.e. BA, BS or equivalent)
- You have substantial GCP experience; additional areas of GXP experience are a plus if the preponderant experience overall is within the biopharmaceutical or pharmaceutical services industry
- You are familiar with regulatory guidance relevant to clinical trials and electronic data (e.g. CFR Chapter 21 Part 11)
- You have recognized expertise in federal and state regulations and defined requirements from the US Food and Drug Administration, Center for Medicare and Medicaid Services, and other relevant bodies such as the International Committee on Harmonization
- You have experience interacting with regulatory health authorities
- You have demonstrated team leadership and staff management and development experience
- You have a risk-based approach to quality; ability to translate/infuse quality knowledge and best practices into research deliverables with creative quality solutions
- You are an experienced leader of cross-functional teams and manage multiple simultaneous projects
- You have a risk-based approach to quality with an ability to translate quality knowledge and best practices from the GXP environment into settings using novel data sources and applications
- You have thorough knowledge of computer systems validation (CSV) and data integrity regulations
- You have outstanding communication skills (written and verbal, both formal and informal)
- You share our commitments to diversity, inclusion, and belonging and are excited to use your skills to optimize quality in new and innovative ways
- 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 clinical research 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 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.