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More>Coco Panda
Quality and validation executive with 14+ years leading GMP quality systems, CSV, process validation, equipment qualification, and regulatory inspection readiness in FDA-regulated life sciences environments. Known for building risk-based validation programs, strengthening data integrity, and leading cross-functional teams through commercial manufacturing, remediation, and global audit cycles.
Led site preparation for three FDA and two Notified Body inspections with no critical observations.
Built enterprise validation governance supporting four manufacturing sites and more than 180 validated systems.
Reduced recurring validation rework and consultant spend by $1.4M through standardized protocols and risk-based testing.
- Directed a 32-member validation and QA team supporting GMP manufacturing, laboratory systems, utilities, facilities, and enterprise quality platforms.
- Established a risk-based validation master plan that reduced protocol cycle time 29% while maintaining full compliance with FDA and EU expectations.
- Partnered with Manufacturing, Engineering, IT, and Regulatory Affairs to close 96% of validation-related CAPAs within approved timelines.
- Led data integrity remediation across LIMS, MES, and QMS platforms, improving audit trail review compliance from 78% to 98%.
- Presented quarterly quality metrics to executive leadership, linking validation readiness, deviation trends, and inspection risk to operating priorities.
- Managed validation quality operations for Class II medical device manufacturing, including equipment qualification, process validation, software validation, and supplier controls.
- Standardized IQ, OQ, PQ, and CSV templates across three sites, improving first-pass approval rate from 71% to 93%.
- Co-led remediation of change control and deviation processes, reducing overdue quality records by 64% within nine months.
- Trained 140 employees on GMP documentation, validation lifecycle requirements, and Part 11 expectations using role-based learning paths.
- Supported successful ISO 13485 surveillance audits by preparing objective evidence, coaching SMEs, and resolving minor findings within deadlines.
Graduate study focused on quality systems, regulatory compliance, validation, and risk management in regulated industries.
Foundation in process engineering, manufacturing systems, statistics, and technical problem solving.
Certified quality auditor credential.
Lean Six Sigma process improvement credential.
Coco Panda
Quality and validation executive with 14+ years leading GMP quality systems, CSV, process validation, equipment qualification, and regulatory inspection readiness in FDA-regulated life sciences environments. Known for building risk-based validation programs, strengthening data integrity, and leading cross-functional teams through commercial manufacturing, remediation, and global audit cycles.
Led site preparation for three FDA and two Notified Body inspections with no critical observations.
Built enterprise validation governance supporting four manufacturing sites and more than 180 validated systems.
Reduced recurring validation rework and consultant spend by $1.4M through standardized protocols and risk-based testing.
- Directed a 32-member validation and QA team supporting GMP manufacturing, laboratory systems, utilities, facilities, and enterprise quality platforms.
- Established a risk-based validation master plan that reduced protocol cycle time 29% while maintaining full compliance with FDA and EU expectations.
- Partnered with Manufacturing, Engineering, IT, and Regulatory Affairs to close 96% of validation-related CAPAs within approved timelines.
- Led data integrity remediation across LIMS, MES, and QMS platforms, improving audit trail review compliance from 78% to 98%.
- Presented quarterly quality metrics to executive leadership, linking validation readiness, deviation trends, and inspection risk to operating priorities.
- Managed validation quality operations for Class II medical device manufacturing, including equipment qualification, process validation, software validation, and supplier controls.
- Standardized IQ, OQ, PQ, and CSV templates across three sites, improving first-pass approval rate from 71% to 93%.
- Co-led remediation of change control and deviation processes, reducing overdue quality records by 64% within nine months.
- Trained 140 employees on GMP documentation, validation lifecycle requirements, and Part 11 expectations using role-based learning paths.
- Supported successful ISO 13485 surveillance audits by preparing objective evidence, coaching SMEs, and resolving minor findings within deadlines.
Graduate study focused on quality systems, regulatory compliance, validation, and risk management in regulated industries.
Foundation in process engineering, manufacturing systems, statistics, and technical problem solving.
Certified quality auditor credential.
Lean Six Sigma process improvement credential.
