Remote Senior IT Validation and Compliance Specialist

KBI Biopharma, Inc.; Northern (KY); Hybrid; USD 125,000 - 165,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Principal Specialist to lead IT Validation and Compliance for enterprise software in a CDMO setting. The role requires ensuring quality across validation lifecycle deliverables and supporting IT quality processes.

You will review change controls, CAPAs, and deviations while ensuring compliance with 21 CFR Part 11 and EU Annex 11. Expect ~10% travel and collaboration with global teams to advance data integrity initiatives and regulatory readiness.

Qualifications

• BS plus 8+ years in QA/GMP environment; MS with 6+ years acceptable.
• Experience in data integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment.
• Knowledge of 21 CFR Part 11 and EU Annex 11.
• Ability to write reports and present information to staff, managers, and clients.

Responsibilities

• Provide QA oversight of validation deliverables for enterprise software projects.
• Review and approve change controls, CAPAs, and deviations.
• Support global data integrity initiatives and IT quality programs.
• Travel approximately 10% domestically and internationally.

Skills

Quality assurance

Regulatory compliance

Data integrity

Documentation

Communication

Education

BS in QA or related field

MS in QA or related field

Tools

Validation lifecycle tools

Job description

KBI Biopharma, Inc. seeks a Principal Specialist to lead IT Validation and Compliance for enterprise software in a CDMO setting. The role requires ensuring quality across validation lifecycle deliverables and supporting IT quality processes.

You will review change controls, CAPAs, and deviations while ensuring compliance with 21 CFR Part 11 and EU Annex 11. Expect ~10% travel and collaboration with global teams to advance data integrity initiatives and regulatory readiness.