Experience

Irish Blood Transfusion Service

• Ireland
• Non-profit Organizations
• 100 - 200 Employee

• Quality Systems Development Manager

  • Nov 2018 - Present

  Development of quality strategy as part of overall IBTS strategyResponsible for review of quality system key performance indicators and stakeholder requirements to develop implementation plans to meet quality strategy objectivesProject manager for discrete projects to fulfil quality system development requirements

• National Quality Assurance Manager

  • Apr 2016 - Nov 2018

  Accountable to the IBTS board, executive management team and National Medical & Scientific Director with direct reporting to Director of Quality and Compliance. Deputised for the Director of Quality and Compliance when required. Manager of National Quality Assurance team with offices in both Dublin and CorkProvided leadership in ensuring the Quality Assurance function of the IBTS maintained a patient and donor safety focus with a model of continuous improvement and compliance.Responsible for management of non-conformances and customer complaints in a timely and effective manner using a risk-based approach.Responsible for change management, document control and training record systems. Direct liaison with Health Products Regulatory Authority for legislative and vigilance affairs including preparation and follow up for regulatory inspections. Show less

• Vigilance Officer

  • Jan 2014 - Apr 2015

  Responsible for analysis and reporting of Blood Establishment serious adverse events (SAE) and reactions (SAR) to the HPRA. Responsible for analysis and reporting of Tissue Establishment SAE and SAR to the HPRA.Provided support and consultation to National Haemovigilance Office with particular responsibility of serological and scientific case study reporting.Performed audit and support for hospitals where the IBTS acts as a blood bank

• Acting Quality Manager

  • Jun 2013 - Jan 2014

  Manager of Quality Assurance office in Munster Regional Transfusion Centre. (MRTC)

• Senior Quality Assurance Scientist

  • Sep 2004 - Jun 2013

  Management of quality control, batch acceptance and microbiology laboratories at MRTC.Implementation and on-going management of quality monitoring, environmental monitoring and bacterial Screening programmes.Auditing and performance management of external service providersDesign and implementation of validation protocols for equipment, techniques, testing protocols and materials.