Debbie McCullough

Head of CMC QA and Qualified Person at Nordic Nanovector ASA
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Contact Information
us****@****om
(386) 825-5501
Location
United Kingdom, GB

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Credentials

  • Eligible Qualified Person under Permanent Provisions
    Royal Society of Chemistry
    Feb, 2021
    - Oct, 2024

Experience

    • Norway
    • Biotechnology Research
    • 1 - 100 Employee
    • Head of CMC QA and Qualified Person
      • Nov 2021 - Present

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Head of Quality Operations, EMEA
      • Apr 2021 - Dec 2021

    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Director of Quality, UK & Ireland
      • Apr 2016 - Apr 2021

      Head of Quality function for UK and Ireland commercial subsidiaries for Merck Biopharma. Responsible Person on UK & Irish WDA’s. Head of Quality function for UK and Ireland commercial subsidiaries for Merck Biopharma. Responsible Person on UK & Irish WDA’s.

    • United Kingdom
    • Retail
    • 200 - 300 Employee
    • Director of Quality & Regulatory Operations
      • Feb 2014 - Apr 2016

      Lead of the quality & regulatory functions for the organisation including manufacturing facilities producing homeopathic, herbal, dietary supplements & cosmetic products, and global 3rd party manufacturers & logistics providers. Lead of the quality & regulatory functions for the organisation including manufacturing facilities producing homeopathic, herbal, dietary supplements & cosmetic products, and global 3rd party manufacturers & logistics providers.

    • Group Quality Director
      • Jul 2013 - Feb 2014

      Group Quality Director overseeing manufacturing facilities producing API's, MDI's, aerosols, liquids, creams, & solid dose forms. Group Quality Director overseeing manufacturing facilities producing API's, MDI's, aerosols, liquids, creams, & solid dose forms.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Site Quality Director
      • Apr 2011 - Jul 2013

      Head of a team of 50 covering all aspects of quality assurance, quality control, regulatory, and validation for medical device & cosmetic products (ISO13485, ISO 22716) in a FMCG environment. Head of a team of 50 covering all aspects of quality assurance, quality control, regulatory, and validation for medical device & cosmetic products (ISO13485, ISO 22716) in a FMCG environment.

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Quality Assurance/Regulatory Affairs Manager
      • Jul 2008 - Apr 2011

      Head of site quality and regulatory for manufacture of in vitro diagnostics (medical devices) in accordance with ISO13485 Head of site quality and regulatory for manufacture of in vitro diagnostics (medical devices) in accordance with ISO13485

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Various
      • Feb 1999 - Jun 2008

      Various roles within the quality function ranging from New Product & Systems Intro Manager, Regulatory, Validation, Value Stream Team Leader (HIV, epilepsy & malaria product streams), QC Manager, QA Team Leader, Operational Quality Officer. Various roles within the quality function ranging from New Product & Systems Intro Manager, Regulatory, Validation, Value Stream Team Leader (HIV, epilepsy & malaria product streams), QC Manager, QA Team Leader, Operational Quality Officer.

Education

  • University of Greenwich
    Master of Science (MSc), Industrial Pharmaceutical chemistry
    2001 - 2004
  • Liverpool John Moores University
    Doctor of Philosophy (PhD), Biochemistry
    1993 - 1999
  • Liverpool John Moores University
    Bachelor of Science (BSc), Biochemistry
    1989 - 1993

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