Principal Specialist - IT Quality

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. 

Position Summary:

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 oversite 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.

Responsibilities:

·       Responsible for auditing and managing process improvements across KBIs 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.

Requirements: 

·       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.

Range $120,000.00 / yr.- $150,000.00 / yr.

About KBI: 

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. For more information, visit www.kbibiopharma.com. 

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. 

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.