Supplier Quality Manager is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus.
The Supplier Quality Manager will:
o Plan, organize, and manage the functions of one or more areas of the Global Supplier Quality system, with respect to implementation and execution of policies and practices.
o Provide Quality Assurance review and/or approval for Supplier related activities impacting GxP operations at BioMarin, including and not limited to Changes, Deviations and Technical Agreements.
o Compile Supplier Performance metrics; including metrics for supplier changes, deviations, and other measures of supplier performance.
o Lead cross-functional Supplier Quality meetings.
o Develop Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
o Provide support of Raw Material Specification review/approval.
The Supplier Quality Manager will require:
o BA or BS in a technical discipline (physical or biological sciences). Equivalent experience may be considered.
o 8+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems (specifically Change Control) preferred.
o 4+ years experience in a management or supervisory position, with direct experience overseeing Supplier Changes preferred.
o Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
o Ability to speak, present data, and defend approaches in front of audiences and inspectors.
o Ability to comprehend technical information related to regulatory expectations.
o Experience with TrackWise preferred.
o Experience working with international project teams preferred.
Call Mairead in LSC on 0214777 329 to discuss this Supplier Quality Manager role in more detail or apply directly via this advert