HC Quality and Regulatory Advisor

Job Description

The HC Quality and Regulatory Advisor ensures healthcare operations comply with internal policies and external regulations. They monitor processes, identify gaps, support audits, and advise teams on quality and regulatory requirements. Responsible for maintaining accurate documentation, tracking compliance, and collaborating across functions to uphold standards, mitigate risks, and drive continuous improvement in healthcare quality and regulatory practices.

Key Responsibilities

• Develop, implement, and maintain SOPs, work instructions, and policies for transportation, fulfillment, and FedEx network facilities (hubs, stations).
• Manage Quality Management System (QMS) administration, continuous improvement, and compliance performance.
• Lead internal, customer, and certification audits, ensuring audit readiness and proper documentation.
• Track, monitor, and resolve corrective and preventive actions (CAPAs) to address quality issues.
• Serve as primary contact for customer quality requests, issues, RFQs, and quality agreements.
• Provide technical guidance and analysis to senior management on quality, compliance, and regulatory matters.
• Interpret complex information to support operational decisions and business improvements.
• Lead and support cross-functional projects and initiatives to enhance processes, compliance, and strategic planning.

Skill & Experience

• Strong Microsoft Office and PC skills for documentation, reporting, and analysis.
• High accuracy and attention to detail in operational and quality tasks.
• Excellent written and verbal communication skills for reporting and customer liaison.
• Strong problem-solving skills to identify, analyze, and resolve quality and compliance issues.
• Effective planning and organizing skills to manage multiple audits, projects, and initiatives.
• Knowledge of SOP, QMS, and regulatory compliance requirements.
• Experience in quality audits, corrective and preventive actions (CAPAs), and process improvement.
• Ability to provide technical guidance and support cross-functional teams.
• Familiarity with transportation, fulfillment, and healthcare operational processes.