GENERAL JOB DESCRIPTION
The Regulatory Affairs / Compliance Manager is responsible for ensuring that all laboratory processes, procedures, and outputs meet defined standards of quality and regulatory compliance. This role is critical in maintaining accreditation and delivering accurate and reliable testing results. The Manager designs and implements policies and procedures, conducts regular audits, manages documentation, and leads staff training initiatives to foster a culture of compliance and maintain the highest standards of quality and safety. This role coordinates cross-functional input.
KEY RESPONSIBILITIES
- Regulatory Oversight: Ensures alignment with relevant regulatory / accrediting bodies (e.g., FDA, CLIA, CAP, ISO, ASHI, etc.) Monitors effectiveness of the QMS through internal audits, indicators and reviews. Prevents fraud, abuse and negligence. Acts as primary point of contact and liaison for regulatory and accrediting bodies (e.g., FDA, CLIA, CAP, ISO, FDA). Coordinates and facilitates external inspections and audits. Promotes safe and lawful operations. Ensures inspection-readiness. Supports a culture of accountability and transparency.
- Governance and Reporting: Reports regulatory to executive leadership. Prepares compliance dashboards. Maintains audit information for investigations. Keeps up-to-date with FDA and State enforcement trends.
- Vendor and Third-Party Compliance: Ensure vendors meet compliance requirements (e.g., HIPAA, FDA registration, etc.). Participates in due diligence with vendor onboarding and contract review, as appropriate.
- Risk Assessment and Incident Management: Leads compliance risk assessments, as needed. Serves as key contact for reporting compliance concerns. Investigates complaints, breaches or suspected fraud.
- Risk Management: Identifies and assesses risk to quality, employee and/or patient safety. Leads Risk Assessments / Projects to mitigate risk and improve resilience of lab processes.
- Electronic Document Management System: Collaborates with the Quality Assurance Manager in maintaining an effective and efficient electronic document management system, including the various elements (e.g., document control system, training matrix maintenance, metrics, etc.). Seeks improvements to the system and acts as Subject Matter Expert.
- Quality Metrics and Performance Monitoring: Develops and analyzes trends and works collaboratively to implement process improvements. Provides KPI metrics to drive improvement.
- Auditing and Monitoring: Plans, schedules and conducts internal quality audits to assess compliance. Identify nonconformities and works with departments to develop corrective/preventive actions. Maintains audit records and follow up on findings. Conducts regular internal audits and risk assessments to monitor adherence to established policies and identify potential areas of non-compliance. Manages the investigation and resolution of any compliance issues or incidents. Performs RA/QA review and disposition of qualification records (plans/protocols, final reports, deviations) for compliance and accuracy in accordance with DPT’s Master Validation Plan and applicable regulatory requirements.
- External Audits / Inspections: Participates in external audits and inspections from regulatory/accrediting bodies or clients. Acts as host of the inspection or in support of the inspection. Facilitates preparation for the inspection / audit and drives the post-inspection responses with QA and leadership.
- Policy and Procedure Development: Develop, review, revise, and implement comprehensive policies, and standard operating procedures (SOPs) to ensure ongoing compliance with evolving regulations.
- Training and Education: Design and deliver ongoing training programs for all laboratory staff on critical regulatory requirements. Assists laboratory management with tools for ensuring staff training and competency assessments are current and documented.
- Continuous Quality Improvement: Leads or participates in quality improvement projects. Encourages a culture of quality and safety within the lab.
- Business Continuity and Corporate Liaison. Develops, executes, manages and revised effective proactive Business Continuity and Quality Risk strategies and plans for the DPT network of laboratories. DPT point person for corporate continuity efforts and disaster preparedness processes, procedures and exercises.
ADDITONAL RESPONSIBILITIES:
- In order to meet Eurofins DPT’s quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins DPT’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.
- Exhibit support of Eurofins DPT’s business philosophy, leadership values, quality objectives, ethical behaviors, customer care and confidentiality standards at all times. Foster a positive work environment, modeling professional behavior
- Pursue and actively participate in professional growth and development opportunities as they relate to and benefit the position and organization.