Sr. Manager with 5 years’ experience managing individual contributors and supervisors in a global environment Proven Quality Assurance leadership skills to ensure IT/Lab/Site compliance with internal procedures and regulatory requirements Demonstrated ability to successfully lead continuous improvement initiatives with effective planning and organization skills • Lead CAPA Investigations • Host FDA/CAP/DOH/Client Audits • Continuous Improvement • Lead Site Misconduct Investigations • Ensure Compliance with Internal SOPs • Software Validation (SDLC) • cGMP/cGCP/CAP/CLIA/ISO • 21 CFR Part 11 SME • Client Relationship Management • Document Management Administrator • Quality Metrics Tracking/Reporting

Highlights:

• CAPA
• 21 CFR Part 11
• SDLC
• Metrics
• FDA
• Quality
• Validation