Senior Director - Compliance & Donor Safety

Overview

The Senior Director, Compliance & Donor Safety provides advanced administrative, fact-gathering, regulatory research, and analytical support to the Chief Operating Officer (COO). Under the direction of the COO, 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. This is a non-supervisory role with no direct reports.

The Senior Director, Compliance & Donor Safety completes assignments within the scope, priorities, questions, and follow-up established by the COO. The position may flag missing information or factual inconsistencies but does not independently initiate or expand a review, determine findings, interpret legal or regulatory requirements on behalf of LiveOnNY, direct departmental action, assign corrective action, or make final legal, disciplinary, clinical, regulatory, or compliance determinations. Matters outside the assigned scope are promptly referred to the COO.

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 COO.
• 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 COO'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 COO'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 COO while remaining within the assigned scope and authority.
• Corrective action and commitment tracking. Tracks assigned corrective and preventive actions, regulatory commitments, audit responses, due dates, and evidence of completion for the COO. The position does not assign, approve, or close corrective actions.
• 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 COO.

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 within the scope and priorities established by the COO, maintaining accountability to the mission, applicable requirements, and COO direction.
• Follows approved SOPs to ensure consistent, high-quality output in assigned work; provides factual quality-assurance support as directed without supervising staff or directing departmental practice.
• 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 COO and supports approved quality improvement and training initiatives as directed.
• Provides assigned factual and administrative support for occurrence reporting, root cause analysis, corrective and preventive action activities, performance improvement initiatives, mock surveys, regulatory readiness activities, and quality reviews under the COO’s direction.
• 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Minimum three years of progressively responsible administrative, compliance, legal-support, quality, audit-support, clinical-support, or investigation-support experience in healthcare or another regulated environment.
• Demonstrated experience collecting and organizing records, maintaining confidential files, tracking deadlines, documenting meetings or interviews, preparing timelines, and drafting accurate factual summaries from source information.
• Demonstrated proficiency in medical terminology and the ability to understand and accurately summarize clinical and administrative processes and records. Strong attention to detail, organization, written communication, and follow-through are required.

Preferred:

• Bachelor's degree in healthcare administration, business administration, health sciences, compliance, legal studies, or a related field.
• Experience in an organ procurement organization, healthcare compliance, clinical operations, quality assurance, donor safety, regulatory readiness, or legal or investigation support.
• Familiarity with CMS Conditions for Coverage, OPTN policies, FDA requirements, and New York State law. Paralegal training or a relevant compliance credential is preferred.

ADDITIONAL REQUIREMENTS:

• Excellent administrative coordination, fact-gathering, organization, attention to detail, written and verbal communication, discretion, and follow-through. Ability to complete multiple directed, sensitive assignments within established priorities and deadlines and to promptly request guidance when scope or authority is unclear.
• Ability to read and accurately summarize medical records, regulations, policies, contracts, financial and business records, professional literature, and technical procedures. Ability to document structured interviews, respond to directed inquiries, and prepare clear chronologies, factual summaries, correspondence, and supporting materials.
• Proficiency with Microsoft 365, spreadsheets, document-management systems, and case or action-tracking tools. Availability outside standard business hours when organizational or regulatory needs require.

PHYSICAL DEMANDS:

• Regularly required to talk or hear.
• Frequently required to sit or stand.
• Occasionally required to walk; use hands to handle objects or controls, reach with hands and arms; and climb or balance.
• Occasionally required to lift or move up to 15 pounds.
• Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Uses reliable transportation in order to travel throughout LiveOnNY’s DSA and, when required, outside the DSA.
• Reasonable accommodation may be provided for qualified individuals with disabilities.

LICENSES:

Regarding any licensure, certification, or other credentials required or preferred by LiveOnNY, LiveOnNY requires they be maintained and current without any infractions or issues.  The Senior Director, Compliance & Donor Safety understands that the Senior Director, Compliance & Donor Safety is responsible for maintaining all qualifications, licenses, certifications, competencies, and other requirements applicable to this position throughout the Senior Director, Compliance & Donor Safety’s employment and for successfully completing all required education, training, competency assessments, and continuing education required by LiveOnNY.

MAINTAIN RESIDENCE WITHIN LIVEONNY’S DESIGNATED SERVICE AREA (DSA)

The Senior Director, Compliance & Donor Safety must maintain a residence within LiveOnNY’s DSA.

This role is designated as a full-time, corporate office-based position.  The primary work location is the assigned LiveOnNY Corporate Office.

Because the essential duties of this position are performed in office, work from home and remote work are not standard arrangements for this position and are prohibited unless the COO grants an explicit exception through prior written authorization in accordance with LiveOnNY’s Work from Home and Remote Work Policy.

LiveOnNY offers a competitive salary & comprehensive benefits package.

403(b) deferred annuityMedical/Vision/DentalTuition reimbursementPaid time OffPet InsuranceLife InsuranceShort and Long Term Disability Insurance

Annual Salary Range: $170,000 - $200,000