Senior Director, Compliance & Donor Safety

Overview

The Senior Director, Compliance & Donor Safety provides advanced administrative, fact-gathering, regulatory research, and analytical support to the Vice President of Compliance and Donor Safety (VP). Under the direction of the VP, the position gathers, organizes, and summarizes information concerning clinical, regulatory, financial, contractual, operational, human resources, and other organization-wide matters. The role requires excellent knowledge of medical terminology, strong administrative and investigation-support skills, and the ability to understand clinical and administrative processes, regulations, and business records. The position also provides functional oversight of assigned Compliance and Donor Safety staff and workstreams as delegated by the VP.

The Senior Director, Compliance & Donor Safety completes assignments and exercises oversight within the scope, priorities, and authority delegated by the VP. The position may assign approved work to designated staff, review work for accuracy and completion, provide coaching, and require correction of administrative or documentation deficiencies within that delegated scope. The position does not independently initiate or expand an investigation, determine final findings, interpret legal or regulatory requirements on behalf of LiveOnNY, direct departmental action outside delegated authority, approve or close corrective actions, or make final legal, disciplinary, clinical, regulatory, or compliance determinations. Matters outside the assigned scope are promptly referred to the VP.

All services performed in this role must be conducted in compliance with applicable federal and state laws, regulations, and oversight requirements, including but not limited to CMS, New York State, FDA, OPTN, and all applicable LiveOnNY policies, standard operating procedures (SOPs), and work instructions.

EXEMPT ROLES – FULL PROFESSIONAL DEDICATION AND AVAILABILITY

This exempt position requires the Senior Director, Compliance & Donor Safety to devote full professional time, attention, and best efforts to LiveOnNY. The Senior Director, Compliance & Donor Safety shall remain available to fulfill the position’s leadership and operational responsibilities inside and outside standard business hours as LiveOnNY’s needs dictate. The Senior Director, Compliance & Donor Safety shall not undertake outside employment, consulting, or business activity, whether compensated or uncompensated, without advance written approval from the Chief Operating Officer in accordance with LiveOnNY’s Conflicts of Interest Policy.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following

• Directed Compliance Review and Investigation Support

• Assigned preliminary fact-finding. Conducts preliminary fact-finding for matters assigned and directed by the VP.

• Directed scope and follow-up. Completes approved fact-gathering steps, information requests, and follow-up and requests direction before changing or expanding the assigned scope.

• Evidence collection and organization. Collects, preserves, labels, and organizes identified records, including emails, policies, system data, logs, contracts, reports, and correspondence, and follows up on missing records as directed.

• Clinical record information support. Locates, organizes, and accurately summarizes factual information from assigned clinical and donation records using medical terminology and process knowledge; refers matters requiring clinical judgment to authorized clinical leadership.

• Business record review. Reviews assigned financial, contractual, human resources, operational, and other business records against provided questions or criteria and flags matters requiring clarification or escalation.

• Structured interview support. Assists with or conducts directed staff interviews using approved questions, accurately documents responses, and submits proposed follow-up items for direction.

• Chronologies and review files. Creates accurate chronologies, evidence indexes, process maps, issue summaries, and organized files that identify the source and status of information.

• Regulatory research. Uses designated primary sources to research assigned federal and state requirements, organizes citations, and prepares factual summaries for the VP's review.

• Directed requirement comparisons. Compares collected information against identified laws, regulations, policies, procedures, work instructions, contracts, or process criteria as directed.

• Issue identification and escalation. Flags inconsistencies, missing evidence, documentation deficiencies, and possible process or control gaps without independently characterizing an issue as a regulatory violation or exposure.

• Objective fact development. Distinguishes verified facts from allegations, assumptions, opinions, and inferences and clearly labels unresolved or unavailable information.

• Draft executive work products. Prepares concise draft summaries, timelines, evidence tables, briefing materials, and organized review packets for the VP's evaluation and approval.

• Regulatory, Audit, and Program Support

• Status updates and directed follow-up. Provides factual status updates and completes follow-up requested by the VP while remaining within the assigned scope and authority.

• Corrective action and commitment oversight. Coordinates and tracks implementation of corrective and preventive actions approved and assigned by the VP or accountable leadership, including due dates, progress, and evidence of completion. The position does not independently determine required corrective actions or approve their closure.

• Audit and survey support. Gathers records, checks data against identified sources, and prepares files for assigned audits, readiness assessments, surveys, inspections, inquiries, and organizational responses.

• QAPI and review support. Provides document collection, research, data organization, meeting support, tracking, and directed follow-up for assigned QAPI, safety, occurrence, root cause, policy-governance, and compliance activities.

• Data compilation and trend support. Compiles assigned records and data, identifies apparent trends using provided criteria, and presents the information for evaluation and direction.

• Administrative Coordination and Records

• Records administration. Maintains complete, secure, and retrievable investigation, audit, occurrence-review, and regulatory-readiness files in approved systems.

• Cross-functional coordination. Coordinates directed information requests and administrative follow-up with departments, external partners, and other stakeholders.

• Confidentiality and escalation. Maintains confidentiality, neutrality, professional skepticism, and proper handling of sensitive information and immediately escalates urgent safety, fraud, privacy, financial, regulatory, or conduct concerns to the VP.

• Regulatory Compliance, Quality, and Performance Improvement

• Works within established guidelines while adhering to regulatory and LiveOnNY policy requirements.

• Uses approved SOPs and regulatory guidance as the framework for assigned processes and practice and drafts proposed revisions only as assigned for authorized review and approval.

• Plans and completes assigned work and oversees delegated staff activities within the scope and priorities established by the VP, maintaining accountability to the mission, applicable requirements, and leadership.

• Follows approved SOPs in own work and monitors the accuracy, timeliness, and completion of assigned staff work within delegated oversight responsibilities.

• Serves as Senior Director, Compliance & Donor Safety in alignment with assigned responsibilities, applicable LiveOnNY policies, SOPs, work instructions, and other requirements formally incorporated into applicable policies or this Job Description.

• Participates in orientation, training, and skill development.

• Identifies, documents, communicates, and appropriately escalates operational, regulatory, contractual, quality, patient safety, workforce safety or organizational concerns.

• Identifies and escalates possible systemic practice issues to the VP and coordinates approved quality improvement and training initiatives within delegated authority.

• Participates in assigned occurrence reporting, root cause analysis, corrective and preventive action activities, performance improvement initiatives, mock surveys, regulatory readiness activities, and quality reviews within delegated authority.

• Assists with implementation and operational integration of approved organizational improvements.

• Maintains confidentiality consistent with LiveOnNY policies and standards.

• Communication And Escalation

• Maintains timely, accurate, and professional communication with Compliance Leadership and Executive Leadership regarding operational matters, workforce matters, regulatory concerns, and organizational priorities.

• Escalates matters requiring Compliance leadership or Executive Leadership review or action through established organizational channels.

• Prepares reports, summaries, recommendations, and other communications as assigned.

• Organizational Stewardship

• Promotes and protects LiveOnNY’s professional reputation and organizational interests in all interactions.

• Protects confidential, proprietary, operational, and sensitive organizational information.

• Demonstrates professionalism, integrity, sound judgement, accountability, and stewardship in the performance of all responsibilities.

Other duties may be assigned.

Qualifications

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required

• Minimum three years...