Principal Specialist - IT Quality

Overview

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 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.

• 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 the global network.
• Global oversight and quality approver for IT related CAPA, change controls (CC), and deviations.

• 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 21 CFR Part 11, and EU Annex 11.

Salary range: $ / yr - $ / yr.

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

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. 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.