Job Description
The Director of Compliance & Safety will serve as the organization's subject matter expert for regulatory compliance, accreditation, quality, and laboratory safety. This individual will be responsible for developing, implementing, and maintaining comprehensive compliance and safety programs while ensuring adherence to CLIA, CAP, OSHA, HIPAA, CMS, OIG, Tennessee Department of Health, and other applicable regulatory requirements. The role will partner closely with laboratory and executive leadership to promote a culture of compliance, quality, and continuous improvement.
Key Responsibilities
Develop, implement, and maintain the laboratory compliance program
Ensure ongoing compliance with CLIA, CAP, OSHA, HIPAA, CMS, OIG, state, and federal regulations
Lead regulatory risk assessments, investigations, and mitigation efforts
Maintain inspection readiness for CLIA, CAP, CMS, payer, and client audits
Oversee document control, policy management, and regulatory record retention
Direct laboratory safety programs, including chemical hygiene, exposure control, emergency preparedness, and waste management
Conduct safety rounds, incident investigations, and risk assessments
Partner with Quality leadership to oversee internal audits, CAPA, RCA, occurrence management, and risk programs
Develop and manage compliance and safety training programs
Collaborate with Revenue Cycle and Billing teams to ensure coding, documentation, and billing compliance
Monitor compliance related to toxicology testing, chain-of-custody processes, and controlled substance requirements
Present compliance updates and reporting to executive leadership and board stakeholders
Lead and mentor compliance, quality, and safety personnel
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
Bachelor's degree in Clinical Laboratory Science, Biology, Chemistry, Healthcare Administration, Regulatory Affairs, Quality Management, or related field
7+ years of laboratory compliance, quality, safety, or regulatory experience
5+ years of leadership experience
Experience within CLIA-certified and CAP-accredited laboratories
Experience in high-complexity laboratory environments
Strong knowledge of CLIA, CAP, OSHA, HIPAA, CMS, and healthcare compliance requirements
Experience with audits, inspections, investigations, and corrective action planning
Knowledge of laboratory quality management systems (QMS)
Nice to Have Skills & Experience
Master's degree in Healthcare Administration, Public Health, Business Administration, or related field
Experience in toxicology and/or molecular diagnostics laboratories
Experience managing regulatory inspections and accreditation surveys
Experience responding to payer and government audits
Background implementing or strengthening compliance programs in growth or turnaround environments
Experience with compliance reporting, dashboards, and KPI development
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.