Chief Laboratory Compliance Officer

Lighthouse Lab Services

Chief Laboratory Compliance Officer

Miami, FL
Full Time
Paid
  • Responsibilities

    Lighthouse Lab Services is actively seeking a seasoned Director of Compliance to join our dynamic clinical laboratory team based in Miami, FL. In this pivotal role, you will spearhead the efforts to ensure strict adherence to all regulatory requirements and industry standards.

    Job Summary:

    As the Director of Compliance, you will be responsible for overseeing and managing all aspects of compliance within the clinical laboratory. Reporting directly to the CEO, you will:

    \- Develop and implement comprehensive compliance programs, policies, and procedures tailored to the clinical laboratory industry and regulatory landscape.

    \- Monitor and assess regulatory developments and industry trends to ensure ongoing compliance with applicable laws, regulations, and standards.

    \- Conduct regular audits, risk assessments, and internal investigations to identify compliance gaps, mitigate risks, and address potential issues promptly.

    \- Serve as regulatory counsel for leadership (Commercial GM, Clinical Lab Director, C-suite, etc.), providing guidance on regulatory matters and strategic initiatives.

    \- Provide regulatory guidance on out-of-pocket genetic testing services, ensuring compliance with relevant regulations and ethical standards.

    \- Own the end-to-end sample journey: from the point a genetic test is ordered to the point the report is delivered to the physician/patient, ensuring adherence to regulatory requirements and quality standards.

    \- Implement rigorous quality control measures to ensure the accuracy and reliability of clinical results.

    \- Ensure adherence to compliance standards throughout the entire sample journey, across all relevant regulatory bodies involved.

    \- Establish and maintain effective communication channels for reporting compliance concerns, incidents, and violations.

    \- Prepare and present compliance reports, metrics, and updates to executive management and the Board of Directors.

     

    Qualifications:

    \- Bachelor's degree in healthcare administration, business, law, or related field. Advanced degree (e.g., JD, MBA) preferred.

    \- Minimum of 5 years of leadership experience in compliance, regulatory affairs, or related fields, preferably within the clinical laboratory industry.

    \- In-depth knowledge of federal, state, and local regulations governing clinical laboratories, including CLIA, HIPAA, and FDA regulations.

    \- Proven track record of developing and implementing compliance programs, policies, and procedures.

    \- Strong analytical, problem-solving, and decision-making skills with the ability to assess complex compliance issues and develop effective solutions.

    \- Excellent communication, negotiation, and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels of the organization.

    \- Detail-oriented with a commitment to accuracy and integrity in compliance activities.

    \- Certified in Healthcare Compliance (CHC), Certified Compliance and Ethics Professional (CCEP), or similar certification preferred.

     

    Compensation + Benefits:

    -130k-150k

    -Health insurance (medical, vision, dental)

    -Retirement plan

    -PTO

    If you are a results-driven compliance professional with a passion for ensuring regulatory compliance and upholding the highest standards of integrity and quality in healthcare, we invite you to apply for this position of Director of Compliance. Take this opportunity to make a meaningful impact on patient care and contribute to this laboratories mission of excellence in diagnostics!

     

    About Us:

    At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 20 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

    It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.

    Lighthouse Lab Services \- 800-838-0602 lighthouselabservices.com

    \#LL3

  • Industry
    Biotechnology