Global
Quality

Tim Buckley

VP, Global Head of Quality

Tim is an experienced Quality professional having spent over 27 years in the pharmaceutical industry supporting sterile semi solids, oral solid dose drug product and active pharmaceutical ingredient manufacture. Tim has held multiple leadership roles within Quality functions at both site and corporate levels, including the position of Qualified Person, demonstrating effective communication skills combined with detailed product quality and compliance knowledge. Tim joined SK biotek in 2018 as the Global Head of Quality with overall responsibility for the development and consistent implementation of SKBT Quality Management System across its network of sites.

In addition to Tim’s primary degree is in Applied Chemistry & Physics (Trinity College Dublin), Tim also has an MSc in Analytical Chemistry (Dublin City University) and a Post Grad. Dip. in Pharmaceutical Manufacturing ((Trinity College Dublin).

Kevin Meehan

Director of Quality, SK biotek Ireland

Kevin Meehan is an experienced Quality and Compliance professional having spent over 20years in the pharmaceutical industry in Ireland supporting oral solid dosage drug product, active pharmaceutical ingredient/chemical intermediate, external manufacturing, and biologics drug substance/product manufacture and release. Kevin’s primary degree is in Bioanalysis (TU Dublin) and he also has a Higher Diploma in Pharmaceutical Production – Bioprocessing (TU Dublin).

Kevin has held leadership roles within Quality and Compliance at both site and corporate levels.  Prior to SK biotek Ireland, Kevin was the Head of QA Small Molecule in the Takeda Ireland Limited Grange Castle facility with the responsibility for all QA operations for API and Drug Product manufacturing, testing and release.

Kevin previously held a global role at SK biotek as the Associate Director of Quality Management Systems between 2019-2021 with the responsibility for QMS support and compliance oversite of activities in both domestic and international sites.

Prior to SK biotek in 2019, Kevin was the QA Compliance Manager in Bristol-Myers Squibb (BMS) Cruiserath Biologics from August 2015 to July 2019. BMS Cruiserath Biologics based in Dublin, Ireland was a $1billion project which consisted of a global biologics release laboratory for the release testing and QP certification of Biologics finished drug product and is a Multi-Product Cell Culture Biologics Drug Substance manufacturing facility for the BMS network. Kevin’s responsibilities included management of the internal, external and regulatory audit programs, site GMP Readiness Program lead, regulatory compliance site lead, and management of suppliers and Quality Agreements. Some of Kevin’s notable BMS Cruiserath Biologics achievements were:

• Site BMS lead for multiple Health Authority inspections with zero critical or major observations (e.g. FDA, HPRA, Russian and COFEPRIS)
• Site GMP Readiness lead for successful GMP switch-on of the Global Biologics Laboratory, Warehouse Cryogenics & Logistics buildings and the Multi Product Cell Culture facility.

Haeok Choi

Director of Quality, SK biotek Korea

Haeok joined SK in 2012; she studied Chemical engineering from Hanyang University. After joining SK biopharm in 2012.
She has more than 20 years experience in quality field. As the quality team director, she is responsible for providing safe medicines to customers throuth quality management. She has contibuted to the past due diligence – in 2017 Sejong Plant passed the Korea Food and Drug Administration du diligenc, and also In 2019 and 2020, Sejong and Daejeon plants passed FDA inspections respectively.