STACY WEAVER

Managed site quality management system (QMS) processes to meet customer, regulatory, and company requirements.

• Administered CAPA, SCAR, and deviation programs, conducting root cause investigations and ensuring timely corrective action follow-up.
• Led management review activities, analyzing KPIs and reporting on quality system performance to support strategic decisions.
• Drove continuous improvement initiatives focused on compliance, quality, and operational effectiveness.
• Led continuous improvement initiatives to enhance compliance and quality standards.
• Planned, conducted, and supported internal, customer, and registrar audits while tracking timely closure of findings.
• Reviewed quality metrics and performance trends to identify risks and drive improvement opportunities.
• Supported quality professionals through coaching, mentoring, training, and performance management.
• Developed, revised, and maintained controlled procedures, work instructions, forms, and quality documentation.
• Managed GMP, GDP, and quality system training compliance programs.
• Performed risk assessments tied to process changes and operational improvements.
• Used Intelex and SAP to track investigations, audit findings, CAPAs, and quality events.
• Assisted customer complaint investigations and cross-functional problem-solving efforts.

• Manage site Quality Management System (QMS) processes to ensure compliance with customer, regulatory, and company requirements.
• Plan, conduct, and oversee internal, customer, and registrar audits while ensuring timely closure of findings.
• Administered CAPA, SCAR, and deviation programs, conducting root cause investigations and implementing corrective actions to mitigate quality issues.
• Analyze quality metrics and performance trends to identify risks and improvement opportunities.
• Lead Management Review activities, including KPI analysis and quality system performance reporting.
• Develop, revise, and maintain controlled procedures, work instructions, forms, and quality documentation.
• Support customer complaint investigations and cross-functional problem-solving efforts.
• Conduct risk assessments associated with process changes and operational improvements.
• Manage GMP, GDP, and quality system training compliance programs.
• Utilize Inteleex and SAP to track investigations, audit findings, CAPAs, and quality events.
• Drove continuous improvement initiatives that strengthened compliance, enhanced quality, and improved operational effectiveness.
• Led development of quality professionals through targeted coaching, mentoring, training, and performance management, enhancing team capabilities.

• Progressed through multiple operational leadership and continuous improvement roles supporting large-scale distribution operations.
• Managed Quality Driven Management (QDM) improvement projects, driving alignment with operational goals.
• Led Value Stream Mapping, Kaizen, and process improvement initiatives.
• Served as QDM Coach and Certified Lean Practitioner.
• Analyzed operational data and performance metrics to identify improvement opportunities.
• Supervised, trained, mentored personnel, enhancing team capabilities and performance.
• Partnered with customers, senior leadership, cross-functional teams to streamline business processes.
• Developed and maintained operational procedures and documentation systems.
• Supported customer-facing projects and issue-resolution activities.