Patrick

Quality Operations and Regulatory Specialist

Summary

Patrick is a seasoned quality professional with expertise spanning regulatory filings, quality operations, and compliance in the pharmaceutical, biotechnology, and medical device industries. With a proven track record in GCP, GLP, and GMP, Patrick has successfully managed quality systems, regulatory inspections, and validations to support domestic and international product development and registration.

Core Expertise

  • Quality Operations 
  • Regulatory Compliance 
  • Validation Processes 
  • Vendor Management 

Career Highlights

  • Head of Quality Operations: Led company-wide quality initiatives, ensuring compliance with GCP, GLP, and GMP standards during product development and process validation. 
  • Director of Quality Operations: Developed and implemented quality systems for US and international compliance, managed audits, supported QC activities during facility startup and tech transfer. 
  • Senior Manager Quality Assurance=: Oversaw manufacturing compliance with cGMP and regulatory standards, managed quality agreements and audits, and directed GMP and GLP operations. 

Contact Us Today