Principal Specialist - IT Quality
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. 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.
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
