Timothy Orszula

Timothy Orszula is an experienced professional in Quality Assurance and Quality Compliance with a robust background in the pharmaceutical industry, currently serving as Product Quality Lead-Development and External QA at Alkermes since 2006. Responsibilities encompass overseeing contract manufacturing organizations, ensuring adherence to quality policies and cGMP, and managing critical quality systems and programs including Product Quality Complaints, Documentation Management, and Internal Audits. Prior roles at Alkermes include Quality Assurance Supervisor and Senior Quality Assurance Associate, where Timothy led numerous initiatives to enhance quality processes and compliance. Additional experience includes a Quality and Regulatory Consultant position at Baxter Healthcare and an Analytical Quality Assurance role at Abbott Laboratories. Timothy holds an MBA from Webster University and a BA in Environmental Science from Lake Forest College.