Gemma Sayers

Gemma Sayers Email and Phone Number

Senior Director Head Global Development Quality Management (GVP) @ Regeneron
Hemel Hempstead, GB
Gemma Sayers's Location
Hemel Hempstead, England, United Kingdom, United Kingdom
Gemma Sayers's Contact Details

Gemma Sayers personal email

n/a
About Gemma Sayers

I am a motivated team leader with over 15 years’ experience in the pharmaceutical industry, in the areas of pharmacovigilance, quality assurance audit, strategy and leadership

Gemma Sayers's Current Company Details
Regeneron

Regeneron

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Senior Director Head Global Development Quality Management (GVP)
Hemel Hempstead, GB
Website:
regeneron.com
Employees:
16494
Gemma Sayers Work Experience Details
  • Regeneron
    Senior Director Head Global Development Quality Management (Gvp)
    Regeneron
    Hemel Hempstead, Gb
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  • Scholars' Education Trust
    Member Board Of Trustees
    Scholars' Education Trust Jul 2024 - Present
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  • Regeneron
    Senior Director Head Global Development Quality Management (Gvp)
    Regeneron Jan 2024 - Present
    Uxbridge Uk
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  • Regeneron
    Head Pharmacovigilance Quality Management Lead
    Regeneron Mar 2022 - Jan 2024
    United Kingdom
    View
  • Regeneron Pharmaceuticals, Inc.
    Director, Pharmacovigilance Quality Management Lead
    Regeneron Pharmaceuticals, Inc. Aug 2020 - Mar 2022
    United Kingdom
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  • Takeda
    Director, Pvqa
    Takeda Jun 2017 - Mar 2020
    London, United Kingdom
    Responsible for the team of 5 QA Manager/Senior Managers, in addition to oversight of QA vendors providing auditor resource. Supervised the implementation of new risk management tools for the scheduling of PV audits across the LOCs, Licence Partners and Distributors. Management of all Quality Issues and Investigations, including CAPA oversight and any necessary escalation. Ensuring execution of planned PV audits, including input into the PV Internal Audit program and provision of expertise and resource to support. Subject matter expert for all PV audits in Takeda, responsible for responding to partners auditing Takeda and regulatory authorities inspecting Takeda. Responsible for coordinating required information for the PSMF from all possible sources.
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  • Takeda
    Interim Senior Director & Pvqa Lead
    Takeda Dec 2017 - Aug 2018
    London, United Kingdom
    • Lead for the PVQA function: team and strategy leader. Including personnel development, talent management and optimisation of resource and activities• Responsible for strategic and tactical audit planning, execution and reporting for PV-Local Operating Company (LOC) audits and Business Partner audits (licence partners & distributors). • Responsible for input into Internal PV Audit program and PV Supplier Audit program and oversight• Responsible for collation and reporting of QA data to the PSMF• Direction of PV Inspections including interaction with regulators, including collation and reporting of responses and review of CAPA completion
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  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Loc Strategy Lead, Bioresearch Quality & Compliance
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Feb 2016 - Jun 2017
    High Wycombe, Buckinghamshire, United Kingdom
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  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Head Of Drug Safety & Local Safety Officer Uk/Ire
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Apr 2013 - Feb 2016
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  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Program Manager, Gsqa
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Sep 2012 - Apr 2013
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  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Senior Specialist, Gsqa
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Sep 2011 - Aug 2012
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  • Johnson & Johnson
    Specialist, Global System Quality Assurance
    Johnson & Johnson Jun 2009 - Aug 2011
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  • Johnson & Johnson
    Operations Scientist
    Johnson & Johnson Feb 2008 - Jun 2009
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  • Johnson & Johnson
    Senior Drug Safety Associate
    Johnson & Johnson Feb 2007 - Feb 2008
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  • Johnson & Johnson
    Drug Safety Associate
    Johnson & Johnson Oct 2005 - Feb 2007
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Gemma Sayers Skills

Drug Safety Pharmaceutical Industry Clinical Trials Gcp Pharmacovigilance Clinical Development Quality Assurance Sop Fda 21 Cfr Part 11 Regulatory Affairs Cro

Gemma Sayers Education Details

Frequently Asked Questions about Gemma Sayers

What company does Gemma Sayers work for?

Gemma Sayers works for Regeneron

What is Gemma Sayers's role at the current company?

Gemma Sayers's current role is Senior Director Head Global Development Quality Management (GVP).

What is Gemma Sayers's email address?

Gemma Sayers's email address is gs****@****jnj.com

What schools did Gemma Sayers attend?

Gemma Sayers attended Newcastle University.

What skills is Gemma Sayers known for?

Gemma Sayers has skills like Drug Safety, Pharmaceutical Industry, Clinical Trials, Gcp, Pharmacovigilance, Clinical Development, Quality Assurance, Sop, Fda, 21 Cfr Part 11, Regulatory Affairs, Cro.

Who are Gemma Sayers's colleagues?

Gemma Sayers's colleagues are John Hanrahan, Melanie Elrod, Qi Yang, Summer Horton, Bryan Maldonado, John Vicente, Anna Campanella.

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