Candace M.

About Candace M.

Curious, creative, constantly learning, continually improving, quality focused, security minded professional who utilizes situational leadership, communication, technical, organizational, analytical, planning and training skills to build deep business and industry expertise, emphasizing teamwork and empowerment to promote customer satisfaction while becoming a committed trusted advisor to an ever-expanding global customer base.

Experience

1. Compliance Program Director

   Axway

   Sep 2017 — Present · Scottsdale, AZ, US

   Serves a member of the Axway Quality, Security and Compliance Office - Primary contact and coordinator globally for all customer quality audits and compliance related topics in federally regulated industries such as healthcare and financial services; provides support to the Customer Success Organization, Sales, R&D and Legal departments. Averages approximately 100+ customer requests annually- Understands and maintains to the Axway Quality Management System (QMS) and the Information Security Management System (ISMS) as an ISO 9001 QMS Auditor/Lead Auditor and an ISO 27001 Lead Auditor / Lead Implementer- Acts as in-house counsel to internal stakeholders for compliance issues, providing guidance for staff questions, solutions to compliance problems and compliant implementation of processes, systems and services, ensuring an always “audit-ready” capacity, turning information into knowledge - Reviews and enhances organizational controls and countermeasures to ensure quality, compliance and security standards are achieved- Maintains compliance with external international standards- Reviews research study audits and reports to ensure program requirements are followed, prepares written reports to management regarding the findings, determines if appropriate corrective actions are taken - Leads or provides input to Axway software validation and services delivery efforts, including ISO 9001, ISO 27001, SOC 2, GDPR, ITIL, GxP, GAMP 5, SSDLC/Agile/Scrum, FDA 21 CFR Part 11/Annex 11, EU FMD, HIPAA, BCP/DR, Validation, Qualification, Compliance, Quality, Security, Regulatory, Competency and Training, Governance, Management Reviews, Internal and External Audits, Operational Planning and Excellence, Documentation/SOPs, Contract Reviews, Change Management, Privacy Concerns, Risk Management, Lean Principles, Continual Improvement to ensure flawless execution for our customers

Education

• GIA (Gemological Institute of America)

  Graduate Gemologist

  2004 — 2010

• Alexander Ramsey High School - Roseville

  College Prep

  1978 — 1981

• University of Wisconsin-Madison

  BA, Psychology, Journalism Minor

  1981 — 1986

Skills

• Jewelry
• Customer Service
• Customer Satisfaction
• Training
• Testing
• Software Implementation
• Business Intelligence
• Change Management
• Analysis
• Software Documentation
• Sdlc
• Root Cause Analysis
• Quality Assurance
• Process Improvement
• Oracle
• Requirements Analysis
• Agile Methodologies
• Team Building
• Management
• Organizing
• Diamonds
• Team Management
• Business Process Improvement
• Project Management
• Retail
• Customer Relations
• Gemology
• Troubleshooting
• Software Project Management
• Saas
• Performance Motivation
• Networking
• Integration
• Cross-Functional Team Leadership
• Conflict Resolution
• Problem Solving
• Project Planning
• Documentation
• Enterprise Software
• IT Management