Responsibilities include: • Coordinate FDA Readiness activities and training needs• Facilitate FDA & DEA inspections, customer audits and third party certifications• Prepare responses for audit observations and verify CAPA completion for observations• Manage internal audit plans, perform system audits and routine Gemba walkthroughs • Oversee supplier management and supplier qualifications activities• Participate on global supplier management team to share audits and resources• Establish Quality Agreements with clients and suppliers • Coordinate critical action teams to promptly assess marketed product issues• Participate on site Quality Review team to discuss quality metrics and audit concerns

Responsibilities included: • Facilitated FDA inspections and customer audits and prepared CAPA responses• Maintained audit plans and conducted internal and external compliance audits • Tracked and verified CAPA completion for audit observations• Assessed product quality issues and compliance concerns for senior management• Reported audit activities and observation trends to senior management • Implemented site Quality Systems Manual

Responsibilities included: • Facilitated FDA inspections and corporate audits and provided CAPA responses• Maintained audit plans and conducted internal and external compliance audits • Tracked and implemented CAPA for audit observations• Assessed product quality issues and compliance concerns• Reported audit activities and observation trends to senior management

Responsibilities included: • Supported audit team with FDA inspections and corporate audits• Conducted internal and external GMP compliance audits • Provided project teams guidance on compliance requirements and regulations • Maintained and trained on Systems Development Life Cycle procedures • Reviewed and managed computer validation deliverables

Responsibilities included: • Project management, computer systems support and validation activities• Coordinated upgrade of an environmental monitoring system• Developed and upgraded databases used to support business needs• Administered the calibration management system

Responsibilities included: • Developed computer validation standards, policies and procedures• Wrote Standard Operating Procedures for computer systems• Developed Disaster Recovery plans for computer systems• Implemented Service Level Agreements with IT groups for validated computer systems• Developed and validated databases and reports supporting business needs

Responsibilities included: • Supported computer systems for approximately 200 clients• Managed a computer hardware and software inventory• Justified and implemented systems for use in a Research and Development facility