Gavin Mcgowan

Gavin Mcgowan Email and Phone Number

Associate Director, Compliance Services - Global Quality and Compliance Excellence at AbbVie @ AbbVie
north chicago, illinois, united states
Gavin Mcgowan's Location
Dublin, County Dublin, Ireland, Ireland
About Gavin Mcgowan

A Quality Assurance and Regulatory Affairs professional with over 15 years’ combined experience in the pharmaceutical and medical device industries, in both private and public sectors, with over 10 years’ experience as a Regulator with the HPRA. I hold a Masters in Biomedical Science and a Bachelor of Science (Hons.) in Anatomy. Expert knowledge of legislative and regulatory requirements for medicinal products and medical devices. Experience conducting and hosting audits as well as regulatory inspections, with extensive experience in CAPA management. A demonstrated track record in communication and teamwork. A self-motivated individual with the ability to think strategically, lead and influence, as well as to think critically, assess information, and problem solve.Graduate from MSc in Biomedical Science, which was delivered through the National Centre for Biomedical Engineering Science (NCBES) at the National University of Ireland Galway.Licensed Emergency Medical Technician (NQEMT), registered with the Pre-Hospital Emergency Care Council (PHECC). Volunteer with the Irish Red Cross.

Gavin Mcgowan's Current Company Details
AbbVie

Abbvie

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Associate Director, Compliance Services - Global Quality and Compliance Excellence at AbbVie
north chicago, illinois, united states
Website:
abbvie.com
Employees:
46234
Gavin Mcgowan Work Experience Details
  • Abbvie
    Associate Director, Compliance Services
    Abbvie Nov 2023 - Present
  • Abbvie
    Senior Manager, Quality Compliance
    Abbvie Oct 2020 - Oct 2023
    Responsibilities:▪ Conducted and reported functional audits of sites in the AbbVie global network, including AbbVie Commercial Affiliate offices.▪ Conducted and reported audits of AbbVie global and site-level suppliers and third-party contract manufacturers’.▪ Delivered training to sites in the global network on GxP Auditor Training.▪ Performed global and site-level quality compliance assessments to support regulatory agency inspection and Notified Body audit readiness.▪ Provided technical and regulatory guidance to global and local plant Quality Operations functions to support the resolution of complex compliance issues.
  • National Children'S Research Centre
    Quality And Regulatory Affairs Manager
    National Children'S Research Centre May 2018 - Sep 2020
    Dublin City, County Dublin, Ireland
    Provided support to the Children’s Clinical Research Unit, and the Cancer Clinical Trials Unit at the National Paediatric Haematology and Oncology Centre.
  • National Children'S Research Centre
    Acting Programme Manager & Quality And Regulatory Affairs Manager
    National Children'S Research Centre Jan 2020 - Apr 2020
    Oversight of the Clinical Research Programme and the Quality and Regulatory Affairs function.
  • Health Products Regulatory Authority (Hpra)
    Scientific Officer (Medical Devices)
    Health Products Regulatory Authority (Hpra) Sep 2017 - Apr 2018
    Dublin City, County Dublin, Ireland
    Device vigilance and compliance assessment for cardiology/cardiovascular, orthopaedic, technical aids, and surgical product families.Lead Auditor - Internal audit program. Device Technical Expert - provided support to the Inspection program.
  • Health Products Regulatory Authority (Hpra)
    Product Manager (Acting) - Medical Devices
    Health Products Regulatory Authority (Hpra) Nov 2016 - Aug 2017
    Product Manager (Acting) - cardiology/cardiovascular, orthopaedic, and surgical product families.Led a team of scientific/technical assessors.Lead Auditor - Internal audit program. Device Technical Expert - provided support to the Inspection program.
  • Health Products Regulatory Authority (Hpra)
    Scientific Officer (Medical Devices)
    Health Products Regulatory Authority (Hpra) Feb 2016 - Oct 2016
    Dublin
    Device vigilance and compliance assessment for In-vitro diagnostic (IVD) medical devices, infusion, transfusion, and dialysis product families.Lead Auditor - Internal audit program. Device Technical Expert - provided support to the Inspection program.
  • Health Products Regulatory Authority (Hpra)
    Product Manager (Acting) - Medical Devices
    Health Products Regulatory Authority (Hpra) Apr 2015 - Jan 2016
    Product Manager (Acting) - In-vitro diagnostic (IVD) medical devices, infusion, transfusion, and dialysis product families.Led a team of scientific/technical assessors.Lead Auditor - Internal audit program. Device Technical Expert - provided support to the Inspection program.
  • Health Products Regulatory Authority (Hpra)
    Scientific Officer (Medical Devices)
    Health Products Regulatory Authority (Hpra) Feb 2011 - Apr 2015
    Dublin
    Device vigilance and compliance assessment for Class I, Class I Sterile, and Class IIb medical devices.Lead Auditor - Internal audit program. Device Technical Expert - provided support to the Inspection program.
  • Health Products Regulatory Authority (Hpra)
    Scientific Officer (Quality Management Systems)
    Health Products Regulatory Authority (Hpra) Oct 2007 - Jan 2011
    Developed, implemented, and maintained the quality management system.Lead Auditor - Internal audit program.
  • Mater Misericordiae University Hospital
    Laboratory Aide (Haematology / Histology)
    Mater Misericordiae University Hospital May 2005 - Sep 2007
    Dublin City, County Dublin, Ireland
  • Boston Scientific
    Product Builder
    Boston Scientific Jun 2003 - Feb 2004
    Galway, County Galway, Ireland

Gavin Mcgowan Skills

Medical Devices Quality System Gmp Iso 13485 Quality Management Capa Biochemistry Internal Audit Laboratory Medical Device Directive Iso9001 Auditor Lean Manufacturing Change Management Corrective And Preventive Action Vigilance Irca Web Content Management Anatomy Post Market Surveillance Iso 14971 Iso 15189 Value Stream Mapping Process Improvement Visual Management Data Quality Ivdd Neuroscience Patient Safety Emergency Medical Direct Patient Care Prehospital Care Bls First Responder Critical Incident Stress Management Child Protective Services Accident Management Trauma Medication Administration Scanning Electron Microscopy Fluorescence Microscopy In Vitro Diagnostics Ivd Regulatory Affairs Oncology Hematology Clinical Trials Good Clinical Practice Project Management Technical Documentation Project Coordination Presentation Skills In Vitro Diagnostics Class Iii Medical Devices

Gavin Mcgowan Education Details

Frequently Asked Questions about Gavin Mcgowan

What company does Gavin Mcgowan work for?

Gavin Mcgowan works for Abbvie

What is Gavin Mcgowan's role at the current company?

Gavin Mcgowan's current role is Associate Director, Compliance Services - Global Quality and Compliance Excellence at AbbVie.

What schools did Gavin Mcgowan attend?

Gavin Mcgowan attended National University Of Ireland, Galway, National University Of Ireland, Galway, National University Of Ireland, Galway, Irish Red Cross Training Centre, Irish Red Cross, Dorset College Dublin, Summerhill College.

What are some of Gavin Mcgowan's interests?

Gavin Mcgowan has interest in Civil Rights And Social Action, Health.

What skills is Gavin Mcgowan known for?

Gavin Mcgowan has skills like Medical Devices, Quality System, Gmp, Iso 13485, Quality Management, Capa, Biochemistry, Internal Audit, Laboratory, Medical Device Directive, Iso9001 Auditor, Lean Manufacturing.

Who are Gavin Mcgowan's colleagues?

Gavin Mcgowan's colleagues are ค๓เ╬ «, Swas Kumar, Korey Keith, Heidi S. Carnahan, Sara Duran Perez, Ana Cardoso, Jake Rounds.

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