Mimi Park

• Ensured vendor compliance with regulatory, safety, and sustainability standards.
• Conducted audits to mitigate supply chain risks through thorough assessments.
• Maintained necessary documentation and certifications for compliance purposes.
• Collaborated with procurement, quality assurance, R&D, and operations teams to align vendor capabilities with business objectives.
• Partnered with finance to manage budgets and initiate cost-saving strategies.
• Drove continuous improvement initiatives in vendor management processes and systems.
• Leveraged market intelligence to identify trends in raw and packaging materials.

• Directed global quality strategy across eight manufacturing and packaging sites, ensuring FDA, EU, and WHO compliance.
• Led a team of over 40 QA/QC professionals in North America and Europe.
• Spearheaded digital transformation of QMS, reducing deviation closure time by thirty-five percent.
• Oversaw global product development, stability programs, and consumer complaint management systems.
• Managed third-party certifications, including GMP, HACCP, Kosher, Halal, Organic, Non-GMO, and USP.
• Served as primary liaison with FDA and regulatory agencies to ensure compliance.

• Standardized global laboratory operations and facilitated analytical method transfers.
• Provided analytical support across international sites to uphold product quality.
• Led design and execution of global stability program in accordance with ICH guidelines.

• Directed research and developed stability protocols for new and reformulated products.
• Ensured audit readiness and maintained regulatory compliance throughout network operations.

Led site QA/QC operations to ensure compliance during FDA inspections.

Implemented comprehensive quality systems that improved FPQ, cycle time, and complaint metrics.

Directed QA and regulatory functions to ensure compliance with FDA, DEA, and global standards.

Led regulatory submissions for IND, NDA, and ANDA while managing QMS and documentation.

• Oversaw audits to maintain rigorous adherence to industry regulations.

Reduced analysis turnaround time by 50% through leadership of R&D and QC operations.

Developed new documentation and training systems to enhance process efficiency.

Progressively advanced through leadership roles in analytical development and quality assurance.

Led development and validation of methods while ensuring GLP compliance.