Sr. Compliance and Program Manager

About the role

Oversee tissue transport and disposition, administrative functions, daily operations and regulatory compliance within the department, ensuring efficiency and alignment with institutional goals.

Job Responsibilities

• Develops, implements, and maintains department-wide standard operating procedures (SOPs) that apply to all clinical locations, ensuring alignment with institutional policies and all applicable federal and state regulations.
• Ensures compliance with federal and state regulations by monitoring existing policies and procedures, maintaining accreditation and ensuring licensing requirements are met.
• Oversee embryo/oocyte transport and disposition coordination.
• Manage staff and their responsibilities.
• Manage staff disciplinary issues and escalate to the Human Resources Department as needed.
• Responsible for onboarding and training staff, monitoring performance and taking corrective action when necessary.
• Identifying training programs and distributing and monitoring staff assignments.
• Participate in NYS DOH inspections and prepares department for audits.
• Ensures timely resolution of any findings.
• Plan, conduct and document internal audits to assess procedural adherence, identify compliance gaps.
• Independently review and approve tissue shipments from external facilities to ensure regulatory compliance and traceability, supporting patient safety and clinic liability mitigation.
• Maintain compliance documentation and tracking for all IVF intended parent (IP) cases, ensuring all regulatory and clinic-specific requirements are met prior to treatment initiation.
• Communicate directly with patients, agencies, and third-party providers to obtain necessary documents, clarify requirements, and ensure understanding of regulatory steps.
• Career Development
• Coordinate patient and partner FDA screening, including scheduling, documentation tracking, results review, eligibility determination, and ensuring timely completion of all required infectious disease testing.
• Track expiration dates and eligibility timelines for FDA testing, donor evaluations, and medical clearance documentation to avoid treatment delays or noncompliance.
• Ensure that all internal systems (EMRs, tracking logs, shared drives) are accurate and consistently updated with patient documentation.
• Review, edit, and provide strategic input on clinic consent forms in collaboration with legal counsel, ensuring regulatory alignment and clarification for patients and staff.
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