[Hiring] Principal Specialist - IT Quality @KBI Biopharma

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This individual will ensure the quality and compliance of the IT infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the review and approval of IT related SOPs and policies and provide quality oversight of change controls, CAPAs, and deviations associated with IT infrastructure. Provides strategic and technical expertise for all GMP IT infrastructure related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements. • Responsible for auditing and managing process improvements across KBI's IT infrastructure • Program oversight and quality authority for IT Compliance related SOPs & Policies • Review and approval of all KBI Software Administrative SOPs within global network • Global oversight and quality approver for IT related CAPA, CC, DEV Qualifications • BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent • Advanced knowledge of IT infrastructure best practices in a pharmaceutical setting • Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment • Demonstrate expert knowledge of 21CFR, Part 11, and EU Annex 11 Requirements • Range $120,000.00 / yr. - $150,000.00 / yr. Company Description KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. Apply tot his job