Shire Global Quality Control Method Introduction and Site Support Lead in Dunboyne, Ireland
This role will serve as the site lead for the Global Quality Control (QC) Team for Method Introduction & Site Support (MI&S) for the Shire single use multi-product biotech facility in Dunboyne, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire.
This role is primarily responsible for leading the Dunboyne MI&S team, QC method validation and transfers, qualification of site specific Standards and reagents, support and authoring of regulatory submissions and leading investigations and problem solving together with site QC labs and partners from Global QC. This is a critical role within the Quality Control organisation to help create value for our patients.
Build processes and procedures to facilitate the transfer of analytical methods into the Quality Control laboratories at the Dunboyne site (Analytical, Biochemical, Cell Biology, Microbiology and Raw Materials).
Hire, develop, lead and coach the Quality Control Method Introduction and Site Support (MI&S) team and drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals
Partner with cross functional stakeholders such as local Quality Control and key groups in global Quality Control (e.g. Analytical Instrument Qualification (AIQ)), Quality Control Technical Services (QCTS), etc.) as well as the Analytical development and Regulatory Affairs groups
Drive decision making with all stakeholders and take decisions including risk management for method implementation and site support
Assure GMP compliant and timely implementation and maintenance of validated status of assays
Support Audits, assure inspection readiness
Identify, lead and drive improvements or remediation for analytical Assays
Drive and support global harmonization and simplification;
Leads the QCMI&S team in meeting targeted site and Tech Ops quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.
BuiIds partnerships within the Quality leadership team (QLT) to create and sustain a culture that demonstrates excellence in quality and continuous improvement.
Creates an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
Responsible to act as an interface (in conjunction with the Head of Quality (QMR)) between Dunboyne Site Quality and the supporting Central Quality support functions (ex. Central Product Testing and others) to ensure site support needs are met.
Drive fulfilment of key performance indicators
Acts as delegate of direct manager as required
A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering). A post-graduate qualification (MSc. or PhD) is desired.
Experience in the biotechnology and/or pharmaceutical industry, with Operational experience of quality laboratories in a fast moving manufacturing environment and demonstrated project management experience.
Experience of analytical transfer programs and method development/validation.
Proven people manager and leader capable of developing people and teams
Proactive at keeping current with literature and latest technologies.
A background in analytical methods (HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays, PCR, capillary electrophoresis and compendia assays).
Knowledge of Analytical Method Development, Analytical Method Validation and Statistical Quality Control. An excellent understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
Experience leading, training and/or implementing root cause analysis and effective investigation practices.
Experience in problem solving (facilitation and application of tools), risk management and decision making
Experience with working in a multinational organisation.
Fluent in English language is a must, communication in multiple languages (French, German) would be a benefit
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.