Senior Manager, Quality Operations (eQMS Operations)

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 (IQM) team to define, maintain, oversee, and optimize the electronic Quality Management System (eQMS). You will provide quality partnership across Flatiron Health’s business through quality programs and quality oversight activities intended to accelerate quality improvement. In this role you will:

• Provide proactive quality leadership as part of the Quality Operations team (Foundations Squad)
• Implement and manage electronic Quality Management Systems such as eQMS; eDMS, and LMS. Develop and/or improve procedures and training for use of the eQMS
• Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements
• Manage electronic document processing, retrieval, and distribution systems (eDMS), electronic learning management system (LMS), electronic Quality Management System (e.g. for Audit, Inspection and CAPA management). Administer document and system access rights and revision control to ensure security of system and integrity of master documents
• Provide IQM review of related quality events such as unplanned/planned deviations
• Oversee harmonization efforts between corporate and IQM procedures and policies
• Ensure QMS systems support proactive audit and inspection readiness.
• Support internal audits, and external audits/inspections of Flatiron’s data and research businesses by clients and/or regulatory authorities
• Collaborate with cross functional teams across Flatiron to implement and maintain systems and processes for controlled, and assignment and administration of training activities
• Foster a quality culture focused on meeting high quality, ethical and regulatory standards
• May coach, lead and mentor direct reports to build a highly capable team through the attraction, training and development of the necessary skilled professionals

Who You Are

You're a proactive Research Quality professional with at least 6 years of experience with activities to support and oversee a fit for purpose QMS. 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 subject matter expertise and experience in development, implementation, and management of electronic Quality Management Systems in a regulated environment. Experience in a clinical development environment (GCP) is strongly preferred.
• You have direct experience related to implementation and use of document control systems and management of controlled documents; training administration systems (LMS) implementation and administration; and quality metrics reporting is required
• You have direct experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs) as well as the associated training plans
• You have direct experience with Food and Drug Administration (FDA) drug, and/or biologic regulations (e.g., 21 CFR parts 11, 312, 314) and related QMS management.
• You have a bachelor’s degree (i.e. BA, BS, or equivalent)
• 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 demonstrated team leadership. Staff management and development experience is desired.
• 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 experience with multiple electronic Quality Management Systems quality (e.g. document control, LMS, audit/CAPA tracking)
• You have 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, E6) and/or 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 direct experience with quality standards and/or certifications (e.g., International Organization for Standardization [ISO] 9000)

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.