Lead, Quality Operations

Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Lead, Quality Operations to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?
What You'll Do
In this role, you'll work with the Quality Operations team and cross-functional research teams to define, maintain, oversee, and optimize Flatiron Health's quality management system. You will provide quality partnership across the business through quality management and quality oversight activities intended to accelerate quality improvement.
This role includes collaborating with key stakeholders to provide guidance on quality matters and leading the key elements of the Quality program against strategic priorities.
In this role you will:

• Implement risk-based Quality Assurance (QA) activities focused on risk assessment; issue identification, escalation, management; corrective/preventive action (CAPA) management, and continuous improvement activities.
• Serve as a quality consultant to project teams providing quality advice regarding topics such as: interpretation of applicable regulatory requirements; research best practices; document management; process development/improvement; audit and inspection readiness; and risk management.
• Support client audit/regulatory authority inspections, including internal facilitation/oversight of associated readiness and/or post-audit action plans.
• Support internal and vendor audit activities, and related follow-up and close-out activities
• Work as an active member of Quality to 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
• Design, implement, and oversee quality training.

Who You Are
You're a kind, passionate and collaborative problem-solver who values the opportunity to think beyond the way things are. In addition, you're a proactive research Quality Assurance professional with at least 4 years of directly applicable experience.

• You have direct experience in Quality Assurance role within a contract research organization (CRO), or biopharma company conducting clinical development or Real World Evidence (RWE)-based research
• You have experience and knowledge in applying Good Clinical Practice (GCP)/Good Pharmacoepidemiology Practices (GPP), and working with teams to facilitate the creation and adoption of processes that support continuous improvement to the quality of our products and services.
• You have substantial experience drafting, reviewing, implementing and optimizing standard operating procedures (SOPs)
• You have experience supporting audits and inspections
• You have a fit-for-purpose approach to quality; ability to translate your quality knowledge and best practices into deliverables with creative quality solutions
• You have the ability to work within and across teams, and manage multiple simultaneous projects
• You have structured communication skills
• You are passionate about our mission to improve healthcare
• You are excited to use your skills to optimize quality in new and innovative ways

Extra credit

• You have direct expertise with Food and Drug Administration (FDA) drug, and/or biologic regulations (e.g., 21 CFR parts 11, 50, 312, 314)
• You have experience with health outcomes or health economic research (e.g. Good Pharmacoepidemiology Practices [GPP]), epidemiology, and/or late-phase clinical trials (e.g., Phase 3B/4)
• You have direct experience with international quality guidelines (e.g., International Council for Harmonization [ICH E6 (R2)]).

Where you'll work
In this hybrid role, you'll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website.
Job Compensation Range
Salary Range: $97,600.00 - $146,400.00
Preferred Primary Location: Raleigh-Durham Office
The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.