Leonora Pearson

Experience

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  AgResearch Ltd

  Jan 2004 - Jan 2009

  Quality Assurance Manager

  I was brought to NZ from the UK by AgResearch to establish their IANZ GLP registered facility (Invoco) in Palmerston North.I was responsible for the development, implementation and maintenance of quality management systems to ensure the continued compliance of the facility at AgResearch. - 2 -Invoco also conducted clinical studies to VICH GCP guidelines, and NZFSA ACVM research standards. As QA Manager I played a crucial role in all clinical and non-clinical studies conducted by Invoco.I was also responsible for the establishment and management of a veterinary parasitology diagnostic unit, servicing AgResearch science departments, Invoco studies and external clients. Following AgResearch’s decision to close their facility in July 2009, I was approached by Estendart to join their team. Show less

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  Estendart Ltd

  Jan 2009 - Jan 2010

  Project Manager/Quality Assurance

  As appointed Study Investigator I was responsible for setting up, quoting, running and reporting, clinical studies according to VICH GCP guidelines. These studies were conducted for some major international animal health companies, to support product registration. I also provided quality assurance support to the QA Manager as required.

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  Invetus Pty Ltd

  Mar 2010 - Mar 2020

  Quality Assurance Manager

  VHR approached me to join their team in Armidale to act as QA Manager and to initiate and implement major improvements to their quality management systems, to ensure the continued compliance of their NATA GLP recognised and ISO9001 accredited facility. This included the writing of numerous SOPs, archive restructure, and the development and maintenance of a number of databases for the recording of SOP and form revision, staff competency, and test item receipt, usage and disposal. I have also been responsible for implementing the necessary quality management systems at VHR’s facility in Hamilton NZ, required to successfully gain IANZ GLP registration in Dec 2010. Other responsibilities include leading the QA team at VHR and performing all QA duties, including auditing, critical phase inspections and facility inspections, relating to clinical and non-clinical studies conducted by VHR in Armidale, VHR NZ, and other organisationally distinct facilities, including VHR’s dedicated dog and cat facility in Casino, and (until recently) VHR’s Analytical Laboratory in North Ryde. Member of the Research Quality Association (RQA) Animal Health Committee.On 01 Dec 16 VHR merged with VetX (dog and cat facility in Casino, NSW) to form a new company Invetus Pty Ltd. Show less

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  TetraQ / Agilex BioLabs

  Mar 2020 - Apr 2022

  Quality Assurance Manager

  Duties and responsibilities include: • Ensuring that TetraQ’s facilities maintain their NATA OECD GLP Recognition. • Fulfilling all OECD GLP QA duties including the auditing of critical study phases.• Preparing and undertaking annual internal facility inspections. • Managing audits by external regulatory authorities (e.g. NATA, FDA) as well as audits by potential / existing sponsors. • Working together with the bioanalytical and toxicology services teams and senior staff to ensure that the work undertaken by TetraQ satisfies current domestic and international regulatory standards (e.g. OECD GLP, ICH, EMA & FDA Guidelines on Bioanalytical Method Validation) • Working together with the leaders of the bioanalytical and toxicology services teams to ensure that the work undertaken by TetraQ satisfies current international industry expectations.• Working together with TetraQ scientists to ensure that all hardware / software is appropriately qualified / validated • Working together with TetraQ management to ensure that any deficiencies in the facilities are documented and resolved via CAPAs.• Working together with TetraQ management on high-level process improvements.• Making recommendations regarding quality policies and coordinating their implementation.• Ensuring that all new staff undergo a GLP induction and conducting annual refresher training for existing staff. Show less

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  QBiotics Group Limited

  May 2022 - now

  Human Clinical Quality Manager

  I joined the QBiotics Human Clinical Development team to review, refine and manage their human clinical quality management systems. I also perform QA duties, as required, in relation to ongoing and upcoming multi-national human clinical trials conducted in accordance with ICH GCP guidelines.