Katie Fuller is a distinguished microbiology consultant with over two decades of expertise in the pharmaceutical sector. As the founder of QualityBiome Consulting, she brings unparalleled experience in contamination control, cleanroom environmental monitoring, and GMP compliance to help pharmaceutical companies achieve sustainable, timely results.
Throughout her career, Katie has demonstrated exceptional versatility, working successfully with both start-up companies and established manufacturers. Her unique background encompasses the creation of new quality control teams from the ground up and the transformation of underperforming operations into industry-leading facilities. This comprehensive experience has positioned her as a trusted advisor capable of addressing the most complex microbiology challenges in pharmaceutical manufacturing.
Currently serving dual roles as Company Microbiologist at CGT Catapult and founder of QualityBiome Consulting, Katie specialises in standardising microbiology functions across networks and advising on contamination control strategies. Her work at CGT Catapult, an independent innovation organisation advancing cell and gene therapies, involves collaborating with QC leads to establish robust environmental monitoring programmes and microbiological testing protocols.
Leadership Excellence
Expert in creating new teams, providing constructive feedback, and driving organisational transformation with proven results.
Contamination Control
Specialises in FMEAs and heat maps for cleanrooms, developing comprehensive contamination control strategies.
Investigational Expertise
Extensive experience leading OOS investigations across cleanrooms, water systems, and product testing scenarios.
Regulatory Compliance
Proven track record with regulatory audits (MHRA, FDA) and supplier assessments, ensuring full GMP compliance.
Career Achievements
- Key player in successful MHRA licensing application with significant audit contributions in both the biopharmaceutical and large pharma small-molecule sectors
- Commissioned and qualified GMP cleanrooms (heat map risk assessments, OQ/PQ, microflora assessments)
- Set up of QC microbiology laboratories including recruitment, equipment qualification, procedural authorship, environmental monitoring programme set up
- LEAN projects including reduction in batch rejects and deviations through process improvements
- Development and delivery of comprehensive training packages to wide and varied audiences
Katie has a specialised educational foundation at the University of Manchester including a PGCert in pharmaceutical microbiology advanced training. She has also undertaken several leadership training certifications and maintains up to date regulatory knowledge within her field. Her expertise spans complex microbial investigations, environmental monitoring programme development, equipment qualification, method verification, and the creation of comprehensive contamination control strategies.
Her previous roles in both leading pharmaceutical companies and start-ups have provided her with deep insights into both large scale small-molecule manufacturing and innovative biopharmaceuticals including cannabinoids and cell and gene therapies. This diverse background enables her to offer unique perspectives and extensive experience in quality assurance challenges across various pharmaceutical sectors.
Katie’s passion for microbiology is both genuine and contagious, and she brings this enthusiasm — along with a strong problem-solving mindset — to every client engagement at QualityBiome Consulting.