Senior Manager, Healthcare Compliance

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com. 

Summary 

The Senior Manager, Healthcare Compliance is responsible for overseeing the development, implementation, and maintenance of the healthcare compliance program at GeneDx, a commercial genomic testing laboratory. This role ensures that laboratory operations, billing practices, and regulatory reporting align with applicable healthcare laws, regulations, and accreditation standards, including CLIA, HIPAA, CMS, OIG guidelines, and state laws. This individual serves as a subject matter expert and key advisor to internal stakeholders on regulatory risk, operational compliance, and ethical business conduct.

Job Responsibilities

Program Management & Oversight

• Manage and continuously improve the laboratory’s corporate compliance program, including policies, procedures, training, and monitoring systems.
• Maintain a compliance calendar and ensure timely execution of audits, reviews, training, and regulatory filings.

Regulatory Compliance

• Ensure compliance with federal and state laws including:
• CLIA, HIPAA, CMS, Medicare/Medicaid regulations
• Anti-Kickback Statute, Stark Law, False Claims Act
• State-specific laboratory laws and reporting requirements
• Monitor updates to healthcare regulations and provide impact analysis and implementation guidance.

Training & Education

• Develop and deliver compliance training programs for laboratory, billing, sales, and support staff.
• Promote awareness of ethical conduct, patient privacy, and proper billing and marketing practices.

Auditing & Monitoring

• Conduct internal audits and investigations related to lab operations, billing, coding, referrals, and marketing activities.
• Implement corrective action plans and monitor remediation efforts.

Incident Management & Reporting

• Investigate reports of noncompliance, regulatory violations, or unethical conduct.
• Maintain compliance hotline procedures and reporting mechanisms.
• Coordinate response to compliance-related incidents, including root cause analysis and regulatory reporting when required.

Collaboration & Advising

• Serve as a compliance advisor to leadership, lab directors, and sales teams.
• Work closely with legal, billing, quality, IT, and HR to manage risk and support compliant operations.

Vendor & Third-Party Oversight

• Review and manage contractual compliance obligations (e.g., Business Associate Agreements, billing service contracts).
• Conduct due diligence on partners and vendors.

People Manager

• No

Education, Experience, and Skills

• Education: Bachelor’s degree in Healthcare Administration, Life Sciences, Law, Business, or a related field.
• Certifications (preferred):
• Certified in Healthcare Compliance (CHC)
• Certified Professional Compliance Officer (CPCO)
• Certified Professional Coder (CPC) or billing compliance credential a plus
• Experience:
• 5-7+ years in healthcare compliance, preferably within a clinical or diagnostic laboratory, hospital, or billing environment.
• Strong working knowledge of laboratory regulations and healthcare billing practices.
• Skills:
• Excellent written and verbal communication
• Strong analytical and investigative abilities
• Ability to manage multiple projects and regulatory deadlines
• High ethical standards and discretion when handling sensitive issues

Work Environment

• Full-time role; remote, hybrid or onsite to be discussed.
• Occasional travel may be required.
• The role may require occasional travel to client sites, with potential exposure to outdoor weather conditions.
• Standard work hours are Monday through Friday, 9 AM to 5 PM EST, with occasional overtime required during peak periods.

Acknowledgements

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.   

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