KBI Biopharma · 15 hours ago
Principal Specialist - IT Quality
United States
Full-time
Remote
Senior Level, Lead/Staff
$120K/yr - $150K/yr
6+ years expKBI Biopharma is a global leader in biopharmaceutical development and manufacturing, empowering life science companies to bring new medicines and vaccines to the world faster. The Principal Specialist - IT Quality will ensure the quality and compliance of the IT infrastructure in a CDMO setting, overseeing IT related SOPs and providing quality oversight of change controls and deviations.
BiopharmaBiotechnologyHealth CareManufacturing
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
Qualification
Required
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
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
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