Security and Regulatory Compliance Manager

Job Description:

Role Summary

• The Security and Regulatory Compliance Manager (SRCM) serves as a subject-matter expert within Client and works to ensure Client is compliant with all Federal and registered regulations including but not limited to FDA, OSHA, HAZMAT, and HIPAA.  
• The SRCM leads internal efforts to ensure compliance with standard operating procedures, policies, document management and regulatory activities.   
• These individuals guide team members to perform internal audits and provide guidance to Client management and staff on security and regulatory requirements.   
• This individual presents reports of security, quality and compliance to management and provides recommendations for improvements.   
• This individual is responsible for security and regulatory compliance at all Client locations 
   

PRIMARY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS: 

• Develops reporting requirements for quality assurance and regulatory to keep management informed and identifies opportunities for improvement 
• Develops and manages the Client internal audit program and reports back to management results and recommendations for improvement 
• Leads training efforts for corporate requirements such as FDA, OSHA, HAZCOM, HAZMAT and HIPAA 
• This individual reports to the Chief Operation Officer who serves as the Client Security Officer and will lead security efforts with guidance from the COO 
• Responds to security questionnaires and ensures ongoing security compliance to HIPAA regulations, state regulations, and customer agreements 
• Works closely with Client and Client IT team members to ensure security compliance 
• Leads security assessments, penetration testing as well as remediation efforts to ensure compliance 
• Provides recommendations and guidance for best practices for documentation management and other quality system requirements 
• Leads efforts to ensure consistency across the company with process documentation and documentation management 
• Implements and maintains the Client Quality Management System and Quality Manual 
• Reviews and confirms internal documentation is complete and accurate 
• Escalates quality issues to appropriate management resource and documents issue and resolution 
• Manages the Client CAPA process and ensures compliance to established CAPA process 
• Works closely with Client safety and risk management team members to ensure Client is compliant with all regulations 
• Bridges communication between operations, program, and leadership team for identified quality improvement projects 
• Proactively researches solutions when internal quality issues arise and brings potential resolutions to leadership when escalating issue 
• Continually ensures quality and work instruction documents are updated in the appropriate SharePoint libraries 
• Manages SharePoint sites related to Client quality and compliance requirements 
• Serves as the lead contact for third party quality and compliance audits and follows up on and closes any gaps identified and completes any needed updates 
• Continuously maintains expertise on all quality and regulatory requirements including but not limited to FDA, OSHA, HAZCOM, HAZMAT, HIPAA and ISO 
• Leads efforts for Client to meet ISO Quality Management System standards 
• Obtains and maintains industry certifications related to quality and compliance 
• Works closely with Client licensing team to obtain and maintain license and permits  

Skills and Qualifications:

QUALIFICATIONS:

MINIMUM: 

• 7 or more years of experience required in a related field (i.e. Security, Quality Management, Regulatory Compliance, etc.) 
• Strong understanding of Security, FDA, OSHA and ISO standards and regulations 
• Requires strong knowledge of Microsoft Office Suite 
• Excellent interpersonal, collaborative and communication skills 
• Excellent training and presentation skills 
• Strong technical, process and healthcare industry knowledge 
• BS/BA degree in related discipline 
• Travel required on average from 5% to 10% 

PREFERRED 

• Master’s Degree in related discipline strongly desired (i.e. Management, Business, etc.)