1. Michael Bonett
Current Location: United Kingdom (Looking to relocate within Europe)
Telephone: +44 75 00 70 2779 (Mobile); Email: mbon008@yahoo.com
Professional Profile
A focused Senior Quality Regulatory Manager, Certified Auditor, Consultant and EU Registered Pharmacist with
over 16 years’ experience and expertise in the research, manufacture and supply of safe, efficacious and cost-
effective quality medical products through risk-based management, auditing and standard process validation and
documentation within the pharmaceutical and medical device industries. Patient and knowledgeable with the ability to
achieve consistent results for compliant business growth and continuous improvement of products. Possesses broad
familiarity with Audit, Good Distribution, Manufacturing, Pharmacovigilance Safety Practices, ISO 9001:2015 and
13485:2016, as applied in the Biological, Pharmaceutical, Originator, Generic, Medical Device, In-Vitro Diagnostic and
Human Tissue Industries. Combines exceptional consultancy strengths with the ability to report on and resolve quality
issues and exhibits a commitment to adhering to standards and regulations. Personal and intellectual standing to command
respect of management, colleagues, auditees, suppliers and authorities. Provides an evidence-based, fair, pragmatic, open
approach.
Areas of Expertise
 Strategic Risk Management and Audit
 Regulation Application through Quality
 Interpretation, Flexibility and Diplomacy
 Communication and Presentation
 Client Relationship Management
 Stakeholder Supplier Management
 Consultancy and Leadership
 Quality Project Management
 Efficiency and Effectiveness
Career Summary
Jan 2016 – Dec 2016: Project Quality Lead – J&J Medical, UK (Contract)
• Risk-rated and audited 40 product suppliers against ISO 9001, ISO 13485 and GDP to enable supply of quality products
• Performed the risk analysis of 20 processes and detected/mitigated risks via preventive action execution in a risk register
• Managed the change control, process design, SOP, WI, quality issues, complaints, adverse reaction and CAPA system
• Provided written recommendations to Business Quality (BQ), Responsible Person (RP), regulatory affairs, IT, process
excellence, operations, supply chain, customer service, business development, commercial and finance departments
• Preparing the organization for the off-site quality management system and on-site Medicines and Healthcare Products
Regulatory Agency (MHRA) regulatory inspection and British Standards Institute (BSI) ISO 9001:2008 surveillance audit
• Overseen the user requirements specification (URS), the design and development and the user acceptance testing
(UAT) of a new Inventory Management System (Atticus TM
) for medicinal products, medical devices and consumables
Key Achievements
• Led a team of 25 experts to design a high-quality, affordable, sustainable supply chain, on-site inventory management
delivery of medicinal products, human tissues, knee (Attune®), hip, spinal implants and consumables to an NHS hospital
• Executed ISO 9001:2015 migration assessment actions and updated quality system to comply 2 years ahead of deadline
Jan 2010 – Dec 2015: Quality Regulatory – UPS Healthcare Supply Chain Solutions, The Netherlands (Perm)
Key Achievements
• Obtained 6 licenses for GDP validated storage facilities (50,000 m2
) and GMP 2°re-packaging for Spanish/Dutch facilities
• Completed due diligence, risk-based auditing and integration of Pieffe (70,000 m2
) and Cemelog (24,000 m2
) acquisitions
by directly managing 2 QA country managers and employing and motivating 2 QA specialists each, in Italy and Hungary
• Upgraded quality system to 100% compliance to EU GDP Guidelines 2013/C 343/01, 6 months before effective date
which was recognized as an impressive practice during regulatory inspection, thus obtaining GMP, GDP and CS licenses
Jan 2014 – Dec 2015: Senior Quality Regulatory Manager Europe
• Maintained responsibility for the quality of 180,000 m2
ambient (15 to 25ºC), cooler (2 to 8ºC), freezer (-20 to -60ºC),
controlled substance (CS) storage space, 12 facilities, 20 transport hubs, 10 GMP 2° re-packaging areas and 25 licenses
• Performed GMDP risk assessment and process validations for receipt, storage, repackaging and qualification of transport
• Implemented class I, II and III medical device clients and a new biological client AbbVie into a licensed and validated
20,000 m2
controlled temperature warehouse including an Active Pharmaceutical Ingredient (API) freezer storage
solution with the necessary redundancy measures due to the high-value, critical supply and nature of the drug substance
Jan 2011 – Dec 2014: Regulatory Affairs Manager EMEA
• Adapted a new and unique method of internal audit of freight and courier transportation by leveraging existing audits
• Provided cost-effective management of regulatory consultants by decreasing consultancy costs via the performance of
research to obtain licenses for new business expansions in UK, Spain, Italy, Poland, Hungary, Czech, Russia and Turkey
• Managed licensing, storage, security, distribution, documentation, transport and import/export of List I and List II Narcotic
and Psychotropic controlled substances thus increasing the range of value added services clients could be provided with
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2. Jan 2010 – Dec 2011: Quality Assurance Supervisor
• Introduced storage and distribution solutions for 3 pharmaceutical, 5 medical devices and 2 In-Vitro Diagnostic clients
• Reviewed Batch Packaging Records for pharmaceutical repackaging and medical device rework for Qualified Persons
Jan 2009 – Dec 2009: Quality Pharmacovigilance Lead – Interdos Pharma Services, The Netherlands (Contract)
• Carried out literature searches, Eudravigilance safety reporting, product complaints and product registrations in EVMDP
• Compiled 10 safety reports - PSURs and highlighted concerns to Qualified Person Pharmacovigilance QPPV / MAH
Key Achievement
• Wrote pharmacovigilance system master file, SOPs for report writing and training that led to 3 successful client audits
Jan 2008 – Dec 2008: Senior Quality Safety Associate – Centocor R&D Janssen J&J, The Netherlands (Contract)
• Provided quality safety surveillance of top selling immunological products such as Remicade, Simponi and Stelara
• Managed central European hub for reporting adverse events for commercial and clinical trial products within EU timelines
Key Achievement
• Performed gap analysis and upgraded quality system for corporate audit and integrated Centocor NV into Janssen BV
Jul 2007 – Dec 2007: Pharmacovigilance Assessor – Medicines Evaluation Board, The Netherlands (Contract)
• Assessed the descriptions of pharmacovigilance systems, risk management plans, periodic safety update and signal
detection reports and highlighted issues of concern to the industry and to the head of regulatory agency for drug safety
Jul 2006 – Jun 2007: Registration Manager – Sandoz (Novartis), The Netherlands (Contract)
• Overseen the preparation of 5 regulatory dossiers (eCTD) for EU submission in terms of quality, safety and efficacy of
generic medicines and biosimilars developed for the European market and manufactured in non-EU countries, e.g. India
Jan 2001 – Jun 2006: Quality Assessor – Medicines Authority (MMA), Malta (Perm)
• Managed product labelling, registrations (quality, safety, efficacy), variations, PSURs, adverse events and safety reports
• Represented Malta and attended Quality and Pharmacovigilance party meetings at the European Medicines Agency
• Supported the Maltese Member of the European Medicines Agency Committee for Medicinal Products for Human Use
Key Achievement
• Contributed as Quality Lead in a project team of 15 experts that set up the Malta Medicines Regulatory Authority to
comply within timelines to all EU medicinal product directives, regulations and guidelines for GMP / GDP / GCP / PV / RA
Further Career History
• Hospital Pharmacist - St. Luke's Hospital, Malta. Community Pharmacist - Qawra Pharmacy, Malta. (Sep – Dec 2000)
Education and Qualifications
MA Integrated Marketing Communications
University of Malta, Centre for Communication Technology (2004)
Dissertation: Attitudes of Pharmacists towards Adverse Drug Reaction Reporting
B Pharm Bachelor of Pharmacy (Industrial Pharmacy)
University of Malta, Faculty of Medicine & Surgery (2000)
Dissertation: Research Manufacture and Testing of Glycerine Suppositories
Professional Development
• ISO 13485 Lead Auditor Certification - Kelmac Group (IRCA - A17584), Gerard Kelly
• Internal Quality Management System Auditor – Internal Quality Assurance Services Ltd. (IRCA - A17153, cert. 566/04)
• Good Distribution Practice Inspection – UK Medicines Healthcare Products Regulatory Agency (MHRA), Bryan Wright
• Quality Systems - Malta Medicines Authority (MMA) Twinning Key Result Area H (MHRA), John Taylor
• Pharmaceutical GMP - David Begg Associates (DBA-NSF), Liz Allanson, Mike Halliday
• GMPs in Storage, Transportation and Cold Chain - European Compliance Academy (ECA)
• EudraVigilance User Training Course – European Medicines Agency (EMA)
• MedDRA Structure and Functions - Maintenance Support Services Organization (MSSO)
• Pharmacoviglance - Irish Health Products Regulatory Agency (HPRA), Niamh Arthur
• Drug Safety Essentials – Vflexx (Rotterdam, the Netherlands), Frits Koster
• Managing People, Managing Change (Malta Institute of Management), The Economic Environment (Maastricht)
• Registered Pharmacist and Authorized Apothecary Inspector - Malta (819) Netherlands (99912383317) UK (2213852)
• Member of European QP Association, European Compliance Academy and the Drug Information Association
Further Information
Publications: A A National Adverse Drug Reaction Reporting System for Malta, Malta Medical Journal, MMJ 16
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3. (2004); 3:31- http://www.um.edu.mt/umms/mmj/showpdf.php?article=65
IT Skills: MS Office, MS ACCESS Database, Statistical Package for the Social Sciences (SPSS), TrackWise
Quality Management System Software, TruVault Document Management System, SUMMIT Training
Languages: English, Italian, Dutch, French, Maltese
References are available on request
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