Jules D'Souza

503A Quality Director at Empower Pharmacy

Speaker

Jules Dsouza joined Empower Pharmacy in November 2023 as the 503A Director of Quality.

Jules brings with him a diverse background in Quality and Compliance leadership. He has led both large and small pharmaceutical companies, including clinical and commercial projects including:

• 503A Quality Director- Head of Quality for the 503A facility; direct and monitor all daily operational activities relating to the quality of compounded products, ensure that the drug preparation process complies with government regulations and standards, and responsibility for all regulatory audits pertaining to quality standards for a 503A compounding pharmacy.
• AGC Biologics Global Director of Corporate Quality Control- standardized workforce planning across the 7 sites in the US, Europe, and Japan, provided Corporate Audits support and led the global implementation of LIMS.
• Pharmalex- Global Director of Quality- Quality consultant and contractor management, including Quality Project/portfolio management.
• KBI Biopharma- Sr. Director/Site Head of Quality- Cell and Gene Therapy cGMP production.
• Qualgen- Sr. Director of Quality (503B)- Warning Letter and 483 remediation, cease-and-desist resolution, in-person meetings at FDA headquarters in the US, and QMS implementation.

Jules lives in Montgomery, Texas, and enjoys speaking at Pharmaceutical industry conferences. He provides current strategies on Quality and Compliance topics while networking with State and Federal regulatory authorities and industry attendees. He attended Oklahoma State University and graduated with a Cellular and Molecular Biology degree. GO POKES!

In his spare time, he likes to travel to ancient monuments and learn about ancient civilizations. He also enjoys playing soccer and tennis with his son and grilling/smoking on his Big Green Egg.