Principal Specialist - Quality Validation

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

## Principal Specialist - Quality ValidationApply: USA - NC - Remote: Full time: Posted Today: R00008615JOB SUMMARYThis individual will ensure the quality of the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the review and approval of enterprise software validation lifecycle deliverables and the quality oversite of change controls, CAPAs, and deviations associated with enterprise software. Provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements. JOB RESPONSIBILITIES* Provide oversight of enterprise software validation from a global perspective:* Responsibility Approximate % of Time Provide quality assurance review and approval for validation lifecycle deliverables of enterprise software projects -* Provide quality assurance review and approval of enterprise software change controls, CAPAs, and deviations -* Provide support for data integrity global initiative - MINIMUM REQUIREMENTS* BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent. Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment. Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11.* Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers, and clients. Ability to read, analyze, and author complex documentation.* Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Approximately 10% travel domestically and international.