Michael Bonett

Born: 07-April-1977
+356 793 76 533 / mbon008@yahoo.com
Professional Profile

A Registered Pharmacist, Consultant, Quality Regulatory Manager, Certified Auditor with over 16 years’
experience in regulation of safe, efficacious, cost-effective quality medicines through risk-based management,
documentation and process validation in pharmaceutical and medical device industries. Patient and
knowledgeable with ability to achieve initiative-driven execution of plans for compliant business growth and
improvement of processes and benefits to your organisation. Possesses expertise in ISO 9001 13485, Audit,
Good Distribution, Manufacturing, Regulatory, Pharmacovigilance and Clinical GXPs, in Biological,
Pharmaceutical, Generic, API, Medical Device, In-Vitro Diagnostic, Human Tissues. Combines exceptional
consultancy strengths with ability to resolve complex issues and exhibits a commitment to adhering to best
practices and regulations. Personal and intellectual standing to command respect of management, colleagues,
cross functional teams, and regulatory authorities. Provides a fair, pragmatic, open, and transparent approach.

Areas of Expertise

 Regulatory Affairs and Auditing  Cross Functional Processes  Leadership and Training
 Key Performance Indicators (KPIs)  Headquater/Affiliate Relationships  Project/ Change Management
 Strategic Risk Management  Client and Supplier Management  Effectiveness and Efficiency

Career Summary
Jan 2017 – present: Quality and Regulatory Pharmaceutical Quality / GMDP – Various, Europe (Consultancy)
 Audit and Analysis of GXP Processes as per EU and International Pharmaceutical Regulations and Guidelines
 Development and delivery of training curriculum for Pharmaceutical Quality Management Systems
 Design of cost-efficient process for management of international product complaints, regulatory system maintenance

Key Achievement
Preparation for US FDA inspection via remediation plan, process mapping and setting-up of end to end improvements

Jan 2016 – Dec 2016: Project Quality Lead – Johnson & Johnson Medical, UK (Contract)
 Managed documentation, adverse reactions, KPIs, regulatory issues, process design, change control and training
 Provided written recommendations to business development, commercial and finance, regulatory and quality affairs,
operations, supply chain, Responsible Persons, IT, process excellence, international affairs and legal departments

Key Achievements
 Reduced complexity of SOPS / processes by mapping out affiliate requirements against global regulatory requirements
 Led a small team of cross-functional experts to design a high-quality, affordable and sustainable product supply chain

Jan 2010 – Dec 2015: Quality Regulatory – UPS Healthcare Supply Chain Solutions, The Netherlands (Perm)

Key Achievements
 Lead and trained two country managers and employing and motivating five specialists each, in Italy and Hungary
 Monitoring and executing agreed KPIs from EMEA head office with national country organizations locally
 Performed strategic risk assessment and process validations for key business, quality and regulatory processes
 Upgraded SOPs to 100% compliance to EU Regulations, 6 months before effective date which was recognized as an
impressive practice during regulatory inspection, thus retaining and obtaining all necessary national licenses

Jan 2014 – Dec 2015: Senior Quality Regulatory Manager Europe – UPS SCS Healthcare
 Maintained responsibility for more than 25 licenses and 10 GMP secondary product re-packaging re-labeling areas
 30% decrease of regulatory consultant’s costs for business expansion in UK, Spain, Italy, Poland, Hungary and Czech

Jan 2011 – Dec 2014: Regulatory Affairs Manager EMEA – UPS SCS Healthcare
 Managed licensing, storage, distribution, and import/export of List I / II Narcotic and Psychotropic controlled substances

Jan 2010 – Dec 2011: Quality Assurance Supervisor – UPS SCS Healthcare (Contract)
 Implemented Global SOPs into Dutch Affiliate organization and successfully passed corporate international audit
 Introduced complaint business processes for pharmaceutical, medical devices and In-Vitro Diagnostic products/clients

Jan 2009 – Dec 2009: Quality Pharmacovigilance (PV) Lead - Interdos Pharma, The Netherlands (Contract)
 Reviewed SOPs and quality manual before successfully passing client audits, thus ensuring regulatory compliance
 Carried out product registrations in medicines database, literature searches, drug safety reporting, and complaints
 Wrote drug safety system master information file, documents and drug safety reports for Medical Qualified Persons

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Jan 2008 – Dec 2008: Senior Quality Safety Associate – Centocor R&D Janssen J&J, The Netherlands (Contract)
 Managed European hub for reporting adverse events for commercial / clinical trial products up to international standards
 Harmonized SOPs to reduce complexity between different regions and across company and departmental divisions
 Mapped process for reporting into flow charts, assessed compliance to reporting and passed corporate regulatory audit

Key Achievement
 Gap analysis and QMS upgrade for clinical safety audit of Centocor that integrated into Janssen (Remicade® / Stelara®)

Jul 2007 – Dec 2007: Pharmacovigilance Assessor – Medicines Evaluation Board, The Netherlands (Contract)
 Assessed descriptions of drug safety systems and reports, risk management plans, and clinical signal detection reports
Jul 2006 – Jun 2007: Registration Manager – Sandoz (Novartis), The Netherlands (Contract)
 Review from EMEA head office of regulatory processes for the international compilation of dossiers for the EU market
 Co-ordination with research and manufacturing site to ensure products and dossiers met both national and EU needs
 Preparation of 5 regulatory dossiers for EU submission in terms of quality, safety, efficacy of generic / bio-similars

Jan 2001 – Jun 2006: Quality Assessor – Medicines Authority (MMA), Malta (Perm)
 Public relations and communications with industry and trade unions regarding regulatory processes and fees
 National, mutual recognition and centralized registration processes and MAH variation and product withdrawals
 Managed product labeling, registrations (quality, safety, efficacy), variations, adverse events and safety reports

Key Achievements
 Leadership and training within a small project team of pharmaceutical experts to set up Maltese Regulatory Authority
 Implemented SOPs for registration of and managing variations to regulatory dossiers submitted by international industry
 Completed registration of several products and processed variations for the local national market (<5000 products)

Sep 2000 – Jun 2006: Community Pharmacist – Blossoms and Qawra Pharmacies, Malta (Part-time)
 Dispensing Medicines to Patients, Inventory Management, Prescriptions, Over-the-counter, Cosmetics, and Consumer

Sep 2000 – Dec 2000: Hospital Pharmacist – St. Luke’s Hospital, Malta (Contract)
 Inventory management, distribution of medical products to hospital wards in Malta National General Hospital Pharmacy

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
 European QP Association and EU Compliance Academy
 Royal Pharmaceutical Society, Drug Information Association
 Registered Pharmacist - UK - 2213852 Netherlands - 99912383317 and Malta - 819
 Authorized Apothecary Pharmacy Inspector in Malta
 Managing People, Managing Change (Malta Institute of Management), The Economic Environment (Maastricht)
 Pharmaceutical Regulatory Affairs and Legal Issues - Pharmacy Dept. University of Malta, Prof Anthony Serracino Inglott
 Pharmaceutical Quality Systems - Malta Medicines Authority (MMA) Twinning Key Result Area H (MHRA), John Taylor
 Internal Quality Management System Auditor – Internal Quality Assurance Services Ltd. (IRCA - A17153, cert. 566/04)
 Drug Safety - Irish Health Products Regulatory Agency (HPRA), Niamh Arthur
 Drug Safety Essentials – Vflexx (Rotterdam, the Netherlands), Frits Koster
 EudraVigilance User Training Course – European Medicines Agency (EMA)
 MedDRA Medical Terminology Structure and Functions - Maintenance Support Services Organization (MSSO)
 ISO 13485 Medical Device Lead Auditor Certification - Kelmac Group (IRCA - A17584, cert. A2021), Gerard Kelly
 GMPs in Pharmaceutical Storage, Transportation and Cold Chain - European Compliance Academy (ECA)
 Pharmaceutical GMP - David Begg Associates (DBA-NSF), Liz Allanson, Mike Halliday
 Good Distribution Practice Inspection – UK Medicines Healthcare Products Regulatory Agency (MHRA), Bryan Wright
 European Union Studies in Institutions, Treaties, and Operations - Personnel Development, Prime Minister Office (Malta)

Further Information
Publications: A National Adverse Drug Reaction Reporting System for Malta, Malta Medical Journal, MMJ 16
(2004); 3:31 - http://www.um.edu.mt/umms/mmj/showpdf.php?article=65
IT Skills: MS Office, MS ACCESS, SPSS, TrackWise, TruVault Document Management, SUMMIT Training
Languages: English, Italian, Dutch, French, Maltese
https://uk.linkedin.com/in/michael-bonett-4022212

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