Principal Specialist - Quality Validation
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About The Position
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. This position resides within the Computer System Quality (CSQ) department within Global Quality. The selected individual will ensure the quality of the enterprise software validation in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the review and approval of enterprise software validation lifecycle deliverables and the quality oversight of Change Controls, CAPAs, and Deviations associated with enterprise software. This individual provides strategic and technical expertise for global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and KBI internal requirements.
