Global Enterprise Software Validation Lead

KBI Biopharma, Inc.; North Carolina; Hybrid; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an IT Validation & Compliance professional to ensure the quality of enterprise software in our GMP CDMO environment.

The role reviews and approves validation lifecycle deliverables and oversees change controls, CAPAs, and deviations related to enterprise software. The ideal candidate provides strategic and technical expertise on global software validation, ensuring compliance with 21 CFR Part 11, EU Annex 11, and internal KBI requirements, with travel up to 10% to

Qualifications

• BS or MS with 6–8+ years in a QA or GMP environment.
• Experience with data integrity, computer system validation, and IT quality in FDA-regulated manufacturing.
• Expert knowledge of 21 CFR Part 11 and/or EU Annex 11.

Responsibilities

• Provide global oversight of enterprise software validation.
• Review and approve validation lifecycle deliverables for enterprise software projects.
• Review and approve enterprise software change controls, CAPAs, and deviations.
• Support data integrity global initiative.

Skills

Data Integrity

Computer System Validation

IT Quality

Regulatory Compliance

FDA Regulated Environment

Education

BS in QA/GMP

MS in QA/GMP

Job description

KBI Biopharma, Inc. is seeking an IT Validation & Compliance professional to ensure the quality of enterprise software in our GMP CDMO environment.

The role reviews and approves validation lifecycle deliverables and oversees change controls, CAPAs, and deviations related to enterprise software. The ideal candidate provides strategic and technical expertise on global software validation, ensuring compliance with 21 CFR Part 11, EU Annex 11, and internal KBI requirements, with travel up to 10% to