Senior Director, Compliance & Donor Safety

LiveOnNY•New York, NY

10d•$170,000 - $200,000

About The Position

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 VP’s direction, the role gathers, organizes, and summarizes information concerning clinical, regulatory, financial, contractual, operational, human resources, and other organization-wide matters. It requires medical terminology knowledge, 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 role completes assignments and exercises oversight within the scope, priorities, and authority delegated by the VP. It 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 scope. It does not independently initiate or expand investigations, 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 referred promptly to the VP. All services must comply with applicable federal and state laws, regulations, oversight requirements, and LiveOnNY policies, standard operating procedures, and work instructions, including requirements from CMS, New York State, FDA, and OPTN. This is an exempt position requiring full professional time, attention, and best efforts. The Senior Director must remain available inside and outside standard business hours as organizational needs dictate and may not undertake outside employment, consulting, or business activity without advance written approval from the Chief Operating Officer under LiveOnNY’s Conflicts of Interest Policy.

Requirements

At least 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.
Proficiency in medical terminology and ability to understand and accurately summarize clinical and administrative processes and records.
Strong attention to detail, organization, written communication, and follow-through.
Excellent administrative coordination, fact-gathering, organization, written and verbal communication, discretion, and follow-through.
Ability to complete multiple directed, sensitive assignments within established priorities and deadlines and 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.
Reliable transportation to travel throughout LiveOnNY’s DSA and, when required, outside the DSA.
Ability to meet the stated physical demands, with reasonable accommodation available for qualified individuals with disabilities.

Nice To Haves

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.

Responsibilities

Conduct preliminary fact-finding for matters assigned and directed by the VP; complete approved fact-gathering and follow-up within scope, requesting direction before changing or expanding it.
Collect, preserve, label, and organize identified records and follow up on missing records as directed.
Locate, organize, and accurately summarize factual information from assigned clinical and donation records, referring matters requiring clinical judgment to authorized clinical leadership.
Review assigned financial, contractual, human resources, operational, and other business records against provided questions or criteria and flag matters requiring clarification or escalation.
Assist with or conduct directed staff interviews using approved questions, document responses accurately, and submit proposed follow-up items for direction.
Create accurate chronologies, evidence indexes, process maps, issue summaries, and organized files identifying information sources and status.
Research assigned federal and state requirements using designated primary sources, organize citations, and prepare factual summaries for the VP’s review.
Compare collected information with identified laws, regulations, policies, procedures, work instructions, contracts, or process criteria as directed.
Flag inconsistencies, missing evidence, documentation deficiencies, and possible process or control gaps without independently characterizing them as regulatory violations or exposure.
Distinguish verified facts from allegations, assumptions, opinions, and inferences and clearly identify unresolved or unavailable information.
Prepare draft summaries, timelines, evidence tables, briefing materials, and review packets for the VP’s evaluation and approval.
Provide factual status updates and complete follow-up requested by the VP within assigned scope and authority.
Coordinate and track corrective and preventive actions approved and assigned by the VP or accountable leadership, including deadlines, progress, and evidence of completion; do not independently determine actions or approve closure.
Gather records, check data against identified sources, and prepare files for assigned audits, readiness assessments, surveys, inspections, inquiries, and organizational responses.
Provide document collection, research, data organization, meeting support, tracking, and directed follow-up for assigned QAPI, safety, occurrence, root cause, policy-governance, and compliance activities.
Compile assigned records and data, identify apparent trends using provided criteria, and present information for evaluation and direction.
Maintain complete, secure, and retrievable investigation, audit, occurrence-review, and regulatory-readiness files in approved systems.
Coordinate directed information requests and administrative follow-up with departments, external partners, and other stakeholders.
Maintain confidentiality, neutrality, professional skepticism, and proper handling of sensitive information; immediately escalate urgent safety, fraud, privacy, financial, regulatory, or conduct concerns to the VP.
Follow established guidelines, regulatory requirements, LiveOnNY policies, approved SOPs, and regulatory guidance in assigned work; draft proposed revisions only when assigned for authorized review and approval.
Plan and complete assigned work and oversee delegated staff activities within the scope and priorities established by the VP.
Monitor the accuracy, timeliness, and completion of assigned staff work within delegated oversight responsibilities.
Participate in orientation, training, and skill development.
Identify, document, communicate, and appropriately escalate operational, regulatory, contractual, quality, patient safety, workforce safety, or organizational concerns.
Identify and escalate possible systemic practice issues to the VP and coordinate approved quality improvement and training initiatives within delegated authority.
Participate 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.
Assist with implementation and operational integration of approved organizational improvements.
Maintain timely, accurate, and professional communication with Compliance Leadership and Executive Leadership regarding operational matters, workforce matters, regulatory concerns, and organizational priorities.
Escalate matters requiring Compliance Leadership or Executive Leadership review or action through established organizational channels.
Prepare reports, summaries, recommendations, and other communications as assigned.
Promote and protect LiveOnNY’s professional reputation and organizational interests; protect confidential, proprietary, operational, and sensitive organizational information.
Demonstrate professionalism, integrity, sound judgment, accountability, and stewardship in performing responsibilities.
Perform other duties as assigned.