Thomas Denton

  • I am driven by patient and public service and solving and resolving problems with durable solutions. It is a privilege to work in the Pharmaceutical and Medical Device industry. I am and a creative and dedicated individual and I work tirelessly to ensure Win-Win solutions are created. I am a deep and continuous learner and I build continual development and improvement into all my teams and projects. I enjoy mentoring and sharing knowledge to empowering others to realise potentials that they never believed they could.

  • With over 10 years of experience in the biopharmaceutical / Pharmaceutical and Medical Device industry, I have built a deep and broad experience and knowledge from simple oral systems to Gene therapy products medical devices from tongue depressors to Machine learning of image processing of positron emission tomography-Magnetic Resonance imaging PET-MRI and cancer detection. I began as a clinician working in paramedicine and have retained my clinical focus throughout my technical pharmaceutical career, I am a pre-viva UK Trainee QP and Eligible RP.

    My Background spans various formulations and organizational sizes, I have worked extensively in pharmaceuticals, biological pharmaceutical , advanced therapy medicinal products (ATMPS), medical devices, and combination products. My quality and manufacturing expertise includes oral dosages, creams, ointments, radiotherapeutics, terminally sterile products, large volume parenteral, aseptic fill finish, Cell (somatic and stem), gene and oligonucleotide, Viral particles.

    I have an extensive history of auditing in both Pharmaceuticals and Medical devices, a proven track record in Quality Control (QC) and Quality Assurance (QA) roles, demonstrating exceptional leadership skills as both a line and matrix leader. He is highly regarded for his ability to transform strategy into practical solutions. I have detailed manufacturing knowledge covering many formulations and have experience of managing scale up and tech transfer including establishing Chemistry, Manufacturing controls (CMC) and manufacturing science & technology (MST) validations and controls. As part of good clinical practice (GCP) work I routinely review Clinical trial applications as part of regulatory pathways.

    I am a GMDP, GCP and expert with a flair for technology and leadership as such I pride myself on being a true “jack of all trades and a master of none, but better than a master of one”. I use my depth and breath of learning to help solve clients problems.

    • Problem to Solutions: I am a proven solution seeker from Global company reorganisation and Quality restructuring, to the technical minutia, my diligent and practical pragmatic has seen me set up supply chains, whole WDAs, MIAs and identify an under torqued bolt.

    • Inspection Readiness: I possess a proven ability to lead preparation of regulatory audits from UK, USA, France, Switzerland, Netherlands and beyond.

    • Auditing: I conduct audits across various pharmaceutical sectors, including medical devices, combination products, nutraceuticals, and cosmetic manufacturing.

    • Sterile Processing: I offer expertise in all aspects of sterile processing, including execution, shop floor quality practices, and coaching for personnel. Using my experience in working in Grade A, B, C,D clean rooms to support others.

    • SOP/Protocol Development: I have a strong track record of developing clear, concise, and effective Standard Operating Procedures (SOPs) and protocols.

    • GMP Training & Presentations: I am a skilled trainer, adept at delivering engaging and informative GMP/GDP/ GCP training sessions and presentations.

    • GMP Facilities SME: I am a Subject Matter Expert (SME) in GMP/GDP/ GCP / compliance and quality for facilities, providing valuable guidance and support.

    • Medical Device Expertise: I focus on Class I, Class II and Class III medical devices that are non-imaging and sterile or non-sterile ensuring technical design and Quality of manufacturing and regulatory compliance.

    • Implementation of Global inspection readiness tool and program of activities in a major pharmaceutical company

    • Development of Contamination risk management tools

    • Development of stability trial and method validation

    • Review of multiple clinical trials going on to gain approval.

    • Onboarding of and importation of over 45 pharmaceutical products on to a UK MIA import license

    • Management of Analytical Method validations for new products

    • IMP Cell Gene viral particulate batch review

    • Global Supply chain establishment to multiple countries.

    • UK and EU WDA and MIA registrations including full QMS establishment.

    • Machine learning Quality technical validation of Image processing for cancer detection and staging

    • Various full site audits for: fore cause, due diligence and routine compliance to applicable standards.

  • English

 AFFILIATIONS

CLIENT FEEDBACK

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company