Senior Director, Compliance & Donor Safety

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.

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.

• →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.

• 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.

• 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.

• 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. 

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.

• 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.

• 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.

• 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.

• 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.

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.

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