Reimagine the infrastructure of cancer care within a technology and science community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem. 

We’re looking for a Lead, Regulatory Compliance Operations to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Are you ready to be the next changemaker in cancer care?

What You’ll Do

In this role, you’ll work with the Regulatory Compliance Operations team in our Clinical Research Business Unit (CRBU) to support our research products, initiatives, and the associated software development lifecycles. The Lead will function as a member of the CRBU team and is responsible for supporting in-process compliance and continuous improvement activities. Such support includes collaborating with key stakeholders and leadership. In addition, you’ll also:

• Provide in-process support to CRBU software engineering teams throughout the lifecycle (SDLC) to support compliance with FDA, EMA, MHRA, and ICH requirements including  21 CFR Parts 820, 312, 11; Annex 11, ICH GCP E6R2.
• Support activities that maintain SOC2 certification.  Partner with Security to support SOC2 audit activities.
• Help develop, standardize, and continuously improve applicable processes and procedures across the CRBU programs as well as implement new initiatives with the rapidly growing team.
• Support issue escalation, management, and improvement plans. 
• Ensure proactive client audit/regulatory authority inspection readiness. Support external audits/inspections as a Subject Matter Expert (SME), including coordinating responses and internal oversight of associated action plans (e.g. CAPAs). Support internal audit activities.
• Support potential and existing client interactions/requests for information.
• Support team with communication and escalation of related risks and issues as required.
• Support initiatives to select and oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and Oversight Plans.
• Lead creation, review and revision of departmental SOPs, and related documents.
• Works closely with Integrated Quality Management (IQM) to support client audits, Computer Systems Validation (CSV) activities, internal audit program, and other QMS related activities
• Support and ensure department compliance with Legal, Privacy & Compliance (LP&C) teams, and Security processes and programs.
• Provide proactive support regarding research best practices, document management (including quality control [QC] checks), process development/improvement, change control, and risk management.

Who You Are

You’re a proactive research quality/compliance professional with at least 2 years of directly applicable experience. 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 a B.A. or B.S. (preferred degree in scientific discipline)
• You have direct knowledge and experience in a GxP environment with focus on GCP, FDA, and ALCOA+
• You have knowledge and experience with data privacy and security frameworks such as HIPAA, GDPR, NIST, CSF
• 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 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 have experience working within a matrixed environment, and in hybrid work environment

Extra credit 

• You have direct experience with software defect, bug reporting and escalation in Agile development releases; proficiency in systems for detecting tracking (e.g. JIRA, BitBucket); experience with enterprise SaaS products running in AWS
• You have experience with GAMP5
• You have direct experience with process improvement methodologies 
• You have worked for a technology company (or have worked directly with software developers)

Life at Flatiron 

At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer: 

• Work/life autonomy via flexible work hours and flexible paid time off
• Comprehensive compensation package
• 401(k) contribution to help you reach your retirement planning goals
• Financial health resources including 1:1 financial advice
• Mental well-being tools and services 
• Parental benefits and policies including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services
• Lifestyle spending account for perks that make sense for you and your family

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning through professional development programs and celebrate Diversity in the workplace.

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.