Global IT Validation & Compliance Lead

KBI Biopharma, Inc.; Jacksonville (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an experienced QA professional to ensure IT validation and compliance across its CDMO operations. You will review and approve validation lifecycle deliverables for enterprise software, and oversee change controls, CAPAs, and deviations in a regulated environment.

The role requires deep knowledge of 21 CFR Part 11 and EU Annex 11, with a focus on data integrity and IT quality. Expect global collaboration with cross-functional teams and approximately 10% travel.

Qualifications

• Experience in Data Integrity and computer system validation in FDA-regulated manufacturing.
• Expert knowledge of 21 CFR Part 11 and EU Annex 11.
• Ability to read, interpret complex regulations and write formal QA documentation.

Responsibilities

• Provide oversight of enterprise software validation from a global perspective.
• Quality assurance review and approval of validation lifecycle deliverables.
• Quality assurance review and approval of change controls, CAPAs, and deviations.
• Support data integrity global initiative.

Skills

Data integrity

FDA GMP knowledge

IT validation

Quality oversight

Education

Bachelor's or Master's in a QA, life sciences, or related field

Job description

KBI Biopharma, Inc. is seeking an experienced QA professional to ensure IT validation and compliance across its CDMO operations. You will review and approve validation lifecycle deliverables for enterprise software, and oversee change controls, CAPAs, and deviations in a regulated environment.

The role requires deep knowledge of 21 CFR Part 11 and EU Annex 11, with a focus on data integrity and IT quality. Expect global collaboration with cross-functional teams and approximately 10% travel.