Who We Are:

FlyteHealth (https://www.flytehealth.com) is a health tech services company focused on diagnosing, treating, and managing obesity and obesity-related diseases. Our company was founded by world-renowned obesity medicine physicians who are affiliated with one of the premier teaching and treatment hospitals in North America, Weill Cornell Medicine/New York Presbyterian.

The Role:

The Compliance & Quality Director is a vital member of the Clincial Leadership Team as the chair of the Compliance Committee. The Compliance & Quality Director has oversight over and operational responsibilities for the Compliance Program at the Company corporate level and at each affiliated practice. The Compliance & Quality Director is responsible for creating a culture of compliance within the Company and its affiliated practices. The Compliance & Quality Director is responsible for further developing the Company’s Compliance Program, including determining its effectiveness and identifying areas for improvement. The Compliance & Quality Director is also responsible for the Company’s internal audit program and ensuring each affiliated practice implements adequate controls to comply with all federal, state, and local laws and regulations.

Clinical Quality Assurance will define and support the quality oversight and management of GCP activities internally at BBGT (and other affiliates as directed) and externally with BBGT vendors, consultants, and service providers, including, but not limited to, quality systems management, document review, and approval. The ideal candidate will have experience working in a GCP practice area, preferably in the biotech/pharmaceutical sector.

Responsibilities:

• Chairs the Company's Compliance Committee;
• Develops annual Compliance Program work plan and risk assessment, identifying areas of risk and anticipated government audit targets;
• Implements essential policies and procedures to achieve the goals of the Compliance Program, in addition to promoting adherence to federal, state, and local laws and regulations;
• Leads regular Quality Management Reviews;
• Serves as the quality representative to improve awareness, visibility, and communication on quality initiatives to support the business’ quality goals and priorities;
• Monitors corporate billing practices, reports findings, and provides performance improvement guidance to the Compliance Committee and applicable Company departments and affiliated practices;
• Designs and administers compliance training and continuing education programs to Company personnel and personnel of its affiliated practices as appropriate;
• Advises on Medicare and Medicaid program guidelines, including program integrity and billing compliance;
• Conducts internal compliance audits and reports findings to the Executive Compliance Committee;
• Updates or drafts compliance policies and procedures, as necessary;
• Issues briefing documents to applicable Company departments and affiliated practices, the Board, Compliance Committee, and regarding legal and regulatory updates and/or relevant government healthcare program changes;
• Oversees the development and daily functions of the Compliance Hotline;
• Conducts investigations of potential compliance violations received through the Compliance Hotline or otherwise;
• Collaborates and consults with the Company’s legal counsel on any research, compliance, legal, and other relevant matters;
• Establishes and maintains our quality assurance programs, systems, and processes to provide appropriate oversight of the clinical network and patient care;
• Develops and implements quality design and quality assurance strategies for clinical programs;
• Be the single point of accountability for identifying and managing the timely resolution of quality issues through our established clients and patients;
• Develops quality assurance plans and systems to ensure all pre-approval of our client and patients programs remain compliant with all applicable regulations and guidelines;
• Works closely with the R&D team on clinical and CRO audit plans for pivotal study programs for GLP1s;
• Creates and champions quality process enhancement initiatives to maintain an environment of continuous improvement;
• Develops and oversees quality systems to support our development activities;
• Establishes and maintains a compliant documentation control system;
• Ensures an effective and compliant vendor qualification program is in place for partners and suppliers;
• Maintains a state of readiness for inspection by regulatory agencies.

Qualifications:

• Minimum 10 years of experience in healthcare compliance;
• Proficient in healthcare compliance and applicable federal/state laws and regulations;
• Financial background with experience in conducting regulatory and quality audits;
• Knowledgeable in health information management;
• Excellent oral and written communication skills, including with executive management and Board members;
• Advanced skills in Microsoft Office, including Word, Excel, and PowerPoint;
• The ability to engage, inspire, build credibility, and trust across all levels of a healthcare organization;
• Ability to collaborate and work in a team environment;
• Strong project management skills;
• Ability to delegate and oversee work performance of others;
• Flexibility as well as the ability to effectively manage deadlines and undertake multiple projects at one time.

Educational Requirements:

• Master’s Degree in business or accounting, or a Law Degree;
• Certification in Healthcare Compliance (CHC, CPCO), Internal Audit (CIA), or Fraud Examination (CFE) preferred.

FlyteHealth Benefits:

• *Eligibility for Essential benefits: Full-time employees regularly working 30+ hours per week
• Comprehensive health, dental and vision insurance
• Equity Shares
• 401(k)
• Discretionary PTO Plan
• Parental leave

FlyteHealth Perks:

• Flexible working hours
• Remote-first Company
• Internet Stipend for remote working
• Paid Company Holidays

FlyteHealth values diversity and is committed to equal opportunity for all persons regardless of their race, religion, color, creed, marital status, age, national origin or ancestry, physical disability, medical condition, sexual orientation, and gender identity.