Security and Regulatory Compliance Manager
Atlanta, Georgia  


We have a Permanent position for "Security and Regulatory Compliance Manager" with one of our direct clients in Atlanta, Georgia.   No third party candidates considered for this position. US citizens and all those authorized to work in the US are encouraged to apply.

Job Description

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.  This individual guide team members to perform internal audits and provides 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   

Required Skills

Qualifications

Minimum

  • 7 or more years of experience required in 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 Skills

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

 

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