Amer Alghabban

Bis 2017, VP GxP Quality Assurance, Compliance & Training, Karyopharm Therapeutics

London, United Kingdom


Pharmaceutical industry
medical communications/information
Pharmacovigilance (PhV)
GPP system auditing
quality assurance
regulatory authority inspections
& medical publishing. •Certified as Lead Auditor b
Postgraduate Diploma in Biological Sciences
Postgraduate Certificate in Clinical Research
First Certificate in Medical Laboratory Sciences
Postgraduate (Qualifying) Certificate in Medical S
GMP & Good Pharmacovigilance Practice (GPP) of Pha
Biotech & Medical Devices. •Substantial experience
HQ operations
as well as auditing (clinical quality assurance) o
GLP & GMP training. •experience in searching a wid
German (Conversational)
French (Conversational)
Persian (Conversational). Publications: 1. Pharmac
sole author 2. Dictionary of Pharmacovigilance (pu
sole author. 3. Dictionary of Drug Development & G
GCP & GLP) (in progress)
Invited speaker at over 82 Int. Confrences


Professional experience for Amer Alghabban

  • Current 6 years and 9 months, since Apr 2017

    Managing Director

    GxP Compliance & Training Partners (GCTP)

    Audits & Training on GCP, GCLP, GLP, GDP & GVP systems. Inspection Support & Responses to Reg. Auths. Formal QA Representation, Risk Management & Eval. SOP Development & Review. Essential Documents (Protocol, Study Reports, ICF, etc.) Compliance audits. FDA 483 Response support. Mock GCP & GVP Reg Auth. Inspections.ISO 9001:2015 Audits. Clin Dev & Pharmacovigilance Gap Analysis. Inspection Support. Review of IB, IMPD, Clinical Protocols, ICFs, CSRs, QM, TMFs. Compliance reviews of promotional materials

  • 1 year and 8 months, Aug 2015 - Mar 2017

    VP GxP Quality Assurance, Compliance & Training

    Karyopharm Therapeutics

    SME on GxP & provide guidance to within Clin & QA. Training to Pre-Clinl, Clin and non-clinical Dev staff. Ensure Tech Ops & CROs provide oversight into process design, scale-up. Ensuring process, analytical & formulation Dev work are managed at CMOs. Manage staff. Oper’ strategy in Clin & CMC Quality dep. Manage strategic/compliance risk assessments, Metrics & CAPA. Liaise with Clin Dev, CRO, & Clin QA to support GCP, GMP & GVP Inspection readiness. Strategic oversight plan

  • 3 years and 1 month, Apr 2010 - Apr 2013

    Head, Global Director Quality Assurance

    Merck Serono

    •Manage the global audit team responsible for the development, implementation & follow-up of audit programs for Global R&D activities. •Establishment & implementation of a risk-based, dynamic, audit program, •Management of compliance of global clin development activities with GCP & regulatory requirements, & regulations. •Review & approve the audit resourcing & allocation to ensure that they are designed to positively support the goals & objectives of the Global R&D QA.^ etc

  • 4 years and 11 months, Apr 2005 - Feb 2010

    Global Head of GxP Quality Assurance

    Arpida Ltd

    Responsible for: 1.Quality Management System (QMS) 2.Assessment of regulatory compliance of Research & Development, GCP, GLP, GMP & safety reporting activities & processes (internal & Contracted) 3.Assessment of regulatory compliance of Research & Development activities & processes (internal & Contracted) 4.Facilitation, Preparation for & Hosting Regulatory Inspections (GCP, GMP, GLP, & GPP): hosted 14 different inspections from FDA & EU Regulatory Authorities 5.Managing the vendor selection

Educational background for Amer Alghabban

  • 2 years and 1 month, Jan 2003 - Jan 2005

    Clinical Research

    University of Surrey

  • 9 months, Oct 1988 - Jun 1989

    Biological Sciences

    Salford University

  • 1 year and 10 months, Oct 1988 - Jul 1990

    Clinical Pharmacology

    Bradford University

  • 10 months, Sep 1988 - Jun 1989

    Medical Laboratory Sciences

    Moston College

  • 10 years and 10 months, Sep 1987 - Jun 1998

    Medical Sciences

    University College Hospital Medical School, London

  • 2 years and 9 months, Oct 1983 - Jun 1986


    Salford University, Manchester


  • English

    First language

  • French


  • German


  • Persian Basic


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