Senior Director, Compliance & Donor Safety

LiveOnNY•New York, NY

10d•$170,000 - $200,000•Onsite

About The Position

The Senior Director, Compliance & Donor Safety provides advanced administrative, fact-gathering, regulatory research, and analytical support to the Chief Operating Officer (COO). Under the COO’s direction, the position gathers, organizes, and summarizes information on clinical, regulatory, financial, contractual, operational, human resources, and other organization-wide matters. The role requires knowledge of medical terminology and the ability to understand clinical and administrative processes, regulations, and business records. It is non-supervisory and has no direct reports. The Senior Director completes assignments within the scope, priorities, questions, and follow-up established by the COO. The position may flag missing information and factual inconsistencies, but does not independently expand reviews, 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 referred promptly to the COO. All work must comply with applicable federal and state laws and oversight requirements, including CMS, New York State, FDA, and OPTN requirements, as well as LiveOnNY policies, standard operating procedures, and work instructions. This exempt position requires full professional time, attention, and best efforts for LiveOnNY, with availability inside and outside standard business hours as organizational needs dictate. Outside employment, consulting, or business activities require advance written approval from the COO. The position is full-time and corporate-office-based at the assigned LiveOnNY Corporate Office. Work from home and remote work are not standard arrangements and are prohibited unless the COO grants a prior written exception. The employee must maintain a residence within LiveOnNY’s designated service area (DSA) and have reliable transportation to travel throughout the DSA and, when required, outside it.

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.
Maintain residence within LiveOnNY’s designated service area.
Use reliable transportation to travel throughout LiveOnNY’s DSA and, when required, outside the DSA.
Maintain all applicable qualifications, licenses, certifications, competencies, and other requirements throughout employment, and complete required education, training, competency assessments, and continuing education.

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 COO.
Complete approved fact-gathering steps, information requests, and follow-up; request direction before changing or expanding assigned scope.
Collect, preserve, label, organize, and follow up on identified records as directed.
Locate, organize, and accurately summarize factual information from assigned clinical and donation records; refer 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 that identify information sources and status.
Research assigned federal and state requirements using designated primary sources, organize citations, and prepare factual summaries for the COO’s review.
Compare collected information against 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 exposures.
Distinguish verified facts from allegations, assumptions, opinions, and inferences, and label unresolved or unavailable information.
Prepare draft summaries, timelines, evidence tables, briefing materials, and review packets for the COO’s evaluation and approval.
Provide factual status updates and complete follow-up requested by the COO within the assigned scope and authority.
Track assigned corrective and preventive actions, regulatory commitments, audit responses, due dates, and evidence of completion; do not assign, approve, or close corrective actions.
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 appropriate handling of sensitive information; immediately escalate urgent safety, fraud, privacy, financial, regulatory, or conduct concerns to the COO.
Work within established guidelines and adhere to regulatory and LiveOnNY policy requirements.
Use approved SOPs and regulatory guidance as frameworks for assigned work, and draft proposed revisions only when assigned for authorized review and approval.
Plan and complete assigned work within the scope and priorities established by the COO, maintaining accountability to the mission, applicable requirements, and COO direction.
Follow approved SOPs to ensure consistent, high-quality output and provide factual quality-assurance support as directed without supervising staff or directing departmental practice.
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 COO and support approved quality improvement and training initiatives as directed.
Provide 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.
Assist with implementation and operational integration of approved organizational improvements.
Maintain confidentiality consistent with LiveOnNY policies and standards.
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 information.
Demonstrate professionalism, integrity, sound judgment, accountability, and stewardship in performing responsibilities.
Perform other duties as assigned.