Joe Day

Senior Consultant, GxPAssure

Joe Day is a senior pharmaceutical quality and manufacturing consultant specialising in sterility assurance, aseptic processing, microbiology and regulatory remediation. A former Director of Sterility Assurance at Sanofi Pasteur and Vice President of Manufacturing Operations at bioLytical Laboratories, he has led FDA, Health Canada, WHO and Notified Body inspections. Joe holds a BSc (Hons) in Microbiology, Biotechnology, Chemistry and Engineering and is a Fellow of the Royal Society of Biology.

With more than 25 years’ experience across pharmaceuticals, biologics, vaccines, medical devices and contract manufacturing, Joe has supported organisations from start-ups to multinational companies. He provides strategic and practical leadership in inspection readiness, FDA Warning Letter and Form 483 remediation, quality system improvement, contamination control, Annex 1 compliance, validation and operational performance. His work combines technical expertise with hands-on coaching, risk-based decision-making and sustainable capability building.

• Leads sterility assurance and aseptic processing programmes, including media fills, cleanroom practices, operator behaviours and process design.
• Develops contamination control strategies aligned with revised EU GMP Annex 1 and global regulatory expectations.
• Prepares sites and teams for FDA, EMA, Health Canada, WHO and Notified Body inspections and regulatory interactions.
• Remediates FDA Warning Letters, Form 483 observations and other regulatory findings through sustainable CAPA and quality-system improvements.
• Assesses and strengthens environmental monitoring, critical utilities, cleaning and disinfection, microbiology and objectionable-organism controls.
• Designs and improves investigations, deviations, OOS, CAPA, change control, management review and validation systems.
• Provides technical leadership for sterilisation, depyrogenation, smoke studies, filter validation, container-closure integrity and process validation.
• Coaches and mentors quality, manufacturing, microbiology and leadership teams to build inspection confidence and long-term compliance capability.