Adam Slater

  • • Identifying rapidly and pragmatically where I can add value to an organisation

    • Working with new or existing teams to make positive contributions and achieve goals

    • Identifying areas for improvement and delivering a continuous improvement ethos

    • Providing leadership and direction and mentoring others

    • Identifying solutions and quick wins especially where the challenge is complex or new to the organisation

    • Delivering the required results

    • Working across different cultures and countries

    • Working ‘outside of my comfort zone’ to bring a ‘new pairs of eyes’ to the table

    • Delivery of knowledge across all levels within an organisation

  • I commenced my career in the pharmaceutical industry within the UK National Health Service in Torbay working initially as a laboratory analyst in the biochemistry department before moving into microbiology and culminating in a role within the analytical chemistry department. I then moved into Stafford Miller/Block Drug a multinational pharmaceutical organisation again within the Quality Control department obtaining roles of increasing seniority and responsibility before moving into the Quality Assurance division. Here I was responsible for CDMOs and CMOs within the UK and EU and responsible for a number of technical transfer projects, in addition to global audit, establishment of QTAs and providing guidance and oversight for changes, deviations and OOS events.

    My next move was to one of the CDMOs I was responsible for, Pharmasol/Bioglan, as Head of QC and ultimately Head of QA. Whilst this was still within the area of small molecules my responsibilities included product development, production validation, analytical method validation and technical transfer. Once again, the next step was to a much larger CDMO, Patheon/Thermo Fisher, where I headed up the QC department comprising 50+ individuals and encompassing stability programme management, incoming packaging control, egress monitoring for cephalosporins and audit.

    I then moved to a very large multinational, Wyeth/Pfizer, responsible for external contract manufacture and responsibilities included change management, assessment of deviations and OOS/OOT events, stability for commercial products, technical transfer, remediation, regulatory inspection, and supply chain management. After seventeen years within the industry either working within CDMOs or having direct responsibility for their management I left to start my own consultancy company.

    Working independently or within larger consultancies, I have provided over 200 audits, US PAI readiness programs, technical transfers, person in plant activities, remediation projects, supply chain optimization projects, EMPQ and PPQ oversight and EU Annex 1 assessments, to a range of companies. These roles have also included interim leadership functions in QA, QC and Operations in addition to leading EU Regulatory Compliance programs. In the last eight years these have predominately been in the areas of cell and gene therapy and have included mammalian/bacterial and viral vectors and based in countries within the UK/Ireland, EU, US, Korea, India, and China. The organizations have included MSD, Lonza, Thermo Fisher, Johnson and Johnson/Mc Neil, Pharmalex, in addition to a very broad range of start ups.

  • • Inspection Readiness US PAI, PDMA, EU and UK GMP/GDP and remediation following inspection

    • UK MHRA registered Compliance Monitor

    • International auditing including, GMP, GLP, GDP, IMP, APIs, Excipients, Packaging, CROs, 3 and 4PLs, ISO 9001/13485/17025 and internal audit

    • Sterile/Aseptic processing SME (microbiology/chemistry/validation/production)

    • Documentation design and publishing (SOPs, Protocols, Reports, Reviews, Risk Assessments)

    • Annex 1 gap analysis, CCS generation and refinement, EM programme development and review

    • N-Nitrosamine and excipient risk assessment

    • GMP introduction and refresher training/Inspection conduct/ISO19011 Lead Auditor/Validation and Technical Transfer training

    • Pharmaceutical Quality Systems expert (development/continual improvement)

    • Provided senior leadership interim roles in QA, QC, Operations, Microbiology, Supply Chain

  • • Head of QA Operations for Lonza UK delivered new quality Management and KPI/Metrics programme, reduced overdue critical quality records to zero and maintained compliance for >1 year. Improved site compliance in training, revised site training programme and improved RFT for deviations, OOS, CAPA

    • Head of QC/Microbiology for Lonza UK, introduced lean lab and improved cycle times for testing

    • Led a regulatory compliance project for Johnson and Johnson UK/EU for top 20 products

    • Supply Chain Transformation lead for Biological Critical Reagents at MSD Netherlands

    • Person in Plant for Bluebird biologics based in CMO Novasep/Thermo Fisher Belgium (viral vector)

    • Transformation lead QC for Achieve Life Sciences at their CDMO Sopharma Bulgaria

    • Inspection readiness lead in QC Microbiology and QA for Porton Biopharma UK

    • Trainer for IRCA Lead Auditor (ISO 19011) for RSSL and delivered bespoke training on Validation for Zoetis Ireland and Tech Transfer for Ono Pharmaceuticals Japan

    • Responsible for EU and then Worldwide regulatory compliance program at CMOs for Wyeth/Pfizer

    • Led remediation program for contract testing laboratory in UK, Mycoplasma Experience, resulting in restoration of suspended GMP license < 8 months

    • Operational Aseptic Processing SME for Lachman Consultants supporting projects in India

    • Hosted successful regulatory inspections with agencies such as US FDA, EMA, MHRA, HPRA, ANVISA. Swiss Medic, TGA, KFDA, PDMA, Russian, Turkish and several Scandinavian agencies

    • Conducted in excess of 200 GDMP/GLP/ISO audits in UK, EU, China, Japan, Korea, India, Pakistan, Brazil, Jordan, Palestine, Israel etc.

  • English - Fluent

    French – Fluent

    German – Basic

    Malay – Basic

 AFFILIATIONS

CLIENT FEEDBACK

  • “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 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

  • “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