Compliance Director Jobs in Rutherford, NJ (NOW HIRING)

Job Description: Description: Position Summary The Compliance Director is responsible for leading the organization’s compliance, regulatory affairs, quality assurance, safety, and risk-management programs across XpresTest operations. This role serves as the senior compliance leader responsible for ensuring adherence to applicable federal, state, local, airport, healthcare, laboratory, clinical research, pharmaceutical, and public health requirements. The Compliance Director will provide strategic oversight of compliance programs while supporting operational excellence, government partnerships, regulatory readiness, and enterprise risk mitigation. The ideal candidate will bring a strong background in one or more of the following areas: •Clinical research compliance •Pharmaceutical or life sciences compliance •Public health programs •Government-funded or government-contracted healthcare programs •Healthcare regulatory affairs •Laboratory or diagnostic operations The Compliance Director will partner closely with Executive Leadership, Operations, Clinical Leadership, Quality Assurance, Human Resources, Legal, Facilities, Information Security, and site leadership to develop, implement, monitor, and continuously improve compliance programs, policies, training, and Standard Operating Procedures. This position plays a critical role in maintaining regulatory readiness, supporting audits and inspections, overseeing corrective and preventive actions, promoting workplace safety, and ensuring the consistent delivery of compliant services across all locations.Requirements: Position Responsibilities 1. Compliance Program Leadership • Develop, implement, and oversee an enterprise-wide compliance program aligned with organizational goals and applicable regulatory requirements. • Provide strategic direction for healthcare, laboratory, privacy, safety, clinical research, pharmaceutical, public health, and operational compliance activities. • Monitor compliance with federal, state, and local requirements, including HIPAA, OSHA, CLIA, CDC guidance, airport authority requirements, public health regulations, and other applicable healthcare standards. • Serve as the organization’s senior subject matter expert on regulatory and compliance requirements affecting XpresCheck operations. • Advise senior leadership on compliance risks, regulatory developments, and recommended mitigation strategies. • Conduct ongoing enterprise compliance risk assessments and develop corrective and preventive action plans. • Maintain compliance calendars, regulatory trackers, reporting schedules, and leadership updates. • Promote a culture of ethics, accountability, transparency, safety, and continuous improvement. 2. Clinical Research, Pharmaceutical, and Public Health Compliance • Oversee compliance activities related to clinical research, pharmaceutical, life sciences, public health, or government-supported healthcare programs. • Ensure adherence to applicable clinical research and regulatory standards, which may include Good Clinical Practice, research documentation requirements, informed-consent processes, protocol adherence, data integrity, and regulatory recordkeeping. • Support compliance obligations associated with government contracts, grants, cooperative agreements, public health initiatives, and agency partnerships. • Monitor changes in clinical research, pharmaceutical, healthcare, and public health regulations that may affect Company operations. • Partner with clinical, laboratory, operational, and external stakeholders to ensure programs are implemented in accordance with approved protocols and regulatory expectations. • Provide compliance oversight for programs involving sensitive health information, participant data, specimen collection, disease surveillance, screening, or health-monitoring activities. • Escalate significant regulatory, privacy, safety, or program-integrity concerns to executive leadership and Legal. 3. Regulatory and Government Program Compliance • Support compliance activities associated with CDC initiatives, public health programs, healthcare partnerships, and government contracts. • Coordinate regulatory responses, documentation requests, agency inquiries, and corrective action plans. • Serve as a senior liaison during inspections, audits, monitoring visits, and regulatory reviews. • Ensure locations maintain required permits, licenses, certifications, regulatory postings, and compliance documentation. • Review government contract and program requirements to ensure operational teams understand and meet applicable obligations. • Maintain awareness of changes in healthcare, laboratory, clinical research, pharmaceutical, privacy, public health, and workplace-safety regulations. • Partner with Legal and executive leadership on significant regulatory interpretations, disclosures, or compliance concerns. 4. Policy, SOP, and Document Control • Lead the development, review, approval, and maintenance of compliance policies, Standard Operating Procedures, work instructions, and regulatory documentation. • Ensure policies and SOPs reflect current laws, agency guidance, industry standards, contractual requirements, and organizational objectives. • Oversee document-control processes, including version management, approvals, distribution, retention, and periodic review. • Ensure policy and procedural changes are communicated and implemented consistently across all locations. • Maintain documentation necessary to support audits, inspections, accreditation activities, investigations, and regulatory reporting. • Partner with operational and clinical leaders to translate complex requirements into practical and sustainable procedures. 5. Auditing, Monitoring, and Quality Assurance • Develop and oversee a risk-based compliance auditing and monitoring program. • Conduct or direct site audits, operational reviews, documentation assessments, and compliance inspections. • Evaluate adherence to privacy safeguards, clinical and laboratory procedures, research protocols, safety requirements, data-integrity standards, and operational controls. • Identify compliance deficiencies and partner with leadership to develop corrective and preventive action plans. • Monitor corrective actions through completion and verify effectiveness. • Analyze recurring findings, trends, and systemic issues and recommend enterprise-level improvements. • Support internal and external audits conducted by government agencies, clients, airport authorities, accreditation organizations, and business partners. • Establish quality metrics and accountability mechanisms that support consistent performance across locations. 6. Investigations and Corrective Action • Lead or oversee investigations involving compliance, privacy, safety, research integrity, data integrity, regulatory, or operational concerns. • Ensure investigations are conducted objectively, consistently, confidentially, and in coordination with Human Resources and Legal when appropriate. • Conduct root-cause analyses and recommend corrective and preventive actions. • Track investigation findings, remediation plans, and completion dates. • Identify patterns of noncompliance and recommend policy, training, staffing, technology, or process changes. • Escalate material concerns promptly to senior leadership. • Support voluntary disclosures or regulatory reporting when required and approved by Legal. 7. Privacy, Data Integrity, and Information Governance • Provide compliance oversight for the collection, access, use, storage, transmission, retention, and disposal of sensitive information. • Ensure compliance with HIPAA and other applicable privacy and data-security requirements. • Partner with Information Security and Legal to address privacy incidents, security concerns, and data-governance risks. • Support policies and controls designed to protect participant, patient, employee, research, and operational information. • Monitor data-integrity practices and ensure records are accurate, complete, traceable, and maintained according to approved requirements. • Investigate suspected falsification, unauthorized access, improper disclosure, or inappropriate handling of sensitive information. 8. Training and Education • Develop and oversee organization-wide compliance and safety education programs. • Deliver or coordinate training related to HIPAA, OSHA, clinical research compliance, pharmaceutical or life sciences requirements, infection prevention, privacy, information security, workplace safety, and corporate ethics. • Ensure new employees receive required compliance education during onboarding. • Develop role-specific training for managers, clinical personnel, operational teams, and employees supporting government or public health programs. • Coordinate refresher training, remediation, and competency assessments. • Track training completion, certifications, qualifications, and regulatory requirements. • Evaluate training effectiveness and revise content based on audit findings, incidents, and regulatory changes. 9. Safety and Risk Management • Provide leadership oversight of workplace safety, infection prevention, biosafety, and operational-risk programs. • Ensure compliance with OSHA standards and applicable safety requirements. • Oversee safety inspections, hazard assessments, incident-reporting processes, and corrective actions. • Partner with leadership to reduce employee injuries, operational incidents, privacy events, and regulatory exposure. • Ensure appropriate use of personal protective equipment and adherence to infection-prevention procedures. • Monitor trends involving safety events, near misses, employee injuries, and operational risks. • Support emergency preparedness and response planning across airport-based and clinical operations. 10. Reporting and Continuous Improvement • Develop compliance dashboards, scorecards, risk reports, and key performance indicators. • Provide regular reports to executive leadership regarding compliance performance, audit findings, investigations, corrective actions, training completion, and emerging risks. • Present complex compliance information in a clear and actionable manner. • Analyze compliance and quality data to identify opportunities for risk reduction and operational improvement. • Recommend technology, staffing, policy, training, and workflow enhancements. • Lead enterprise compliance initiatives and special projects. • Support strategic planning for new programs, partnerships, locations, and government opportunities. 11. Cross-Functional and External Collaboration • Partner with Executive Leadership, Operations, Clinical Leadership, Quality Assurance, Human Resources, Legal, Information Security, Facilities, Finance, and site leadership. • Advise business leaders on compliance implications before launching new services, locations, programs, or partnerships. • Build effective relationships with government agencies, public health partners, healthcare organizations, laboratories, research partners, airport authorities, and outside consultants. • Communicate compliance expectations clearly and influence stakeholders at all levels of the organization. • Serve as a trusted advisor while balancing regulatory requirements with operational needs. Minimum Qualifications • Bachelor’s degree in Public Health, Healthcare Administration, Nursing, Life Sciences, Clinical Research, Regulatory Affairs, Pharmacy, Compliance, Business Administration, Occupational Health and Safety, or a related field required. • Minimum of five years of progressive experience in compliance, regulatory affairs, quality assurance, clinical research, pharmaceutical or life sciences operations, public health, government healthcare programs, laboratory operations, or a related regulated environment. • Demonstrated experience leading or significantly contributing to compliance programs, audits, investigations, risk assessments, and corrective action management. • Experience developing and implementing policies, SOPs, training programs, and compliance controls. • Strong knowledge of applicable healthcare and regulatory frameworks, including HIPAA, OSHA, CLIA, infection-prevention requirements, privacy standards, and government program expectations. • Experience working within clinical research, pharmaceutical, public health, government, healthcare, laboratory, or similarly regulated operations. • Experience supporting regulatory inspections, government reviews, client audits, or accreditation activities. • Strong knowledge of data integrity, documentation standards, privacy, and confidential-information handling. • Demonstrated ability to assess risk, interpret regulations, and translate requirements into practical operating procedures. • Strong leadership, analytical, organizational, investigative, and problem-solving skills. • Excellent written and verbal communication skills, including executive presentations and employee training. • Ability to collaborate with clinical, operational, legal, human resources, information-security, and government stakeholders. • Proficiency with Microsoft Office Suite, compliance reporting systems, document-control tools, and learning-management systems. • Ability to travel regularly to airport-based and field locations. Preferred Qualifications • Master’s degree in public health, Healthcare Administration, Regulatory Affairs, Clinical Research, Life Sciences, Law, Business Administration, or a related discipline. • Experience supporting federal government agencies, public health authorities, or government-funded healthcare programs. • Experience in clinical trials, pharmaceutical operations, research compliance, diagnostic testing, disease surveillance, or emergency public health response. • Familiarity with Good Clinical Practice, research protocols, informed consent, institutional review processes, or regulated clinical documentation. • Experience working with the CDC, FDA, NIH, state or local health departments, or other government agencies. • Professional certification such as: Certified in Healthcare Compliance Certified in Healthcare Privacy Compliance Certified Professional in Healthcare Quality Regulatory Affairs Certification Certified Clinical Research Professional Certified Clinical Research Associate Certified in Public Health Certified Safety Professional Comparable compliance, quality, research, regulatory, or safety credential