Summary

This 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 description

Job Summary

This 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
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.

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

Company overview

KBI Biopharma is an award-winning global contract development and manufacturing organization (CDMO) that provides fully integrated, accelerated drug development and biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Founded in 1996 and now part of JSR Life Sciences, KBI has established itself as a next-generation CDMO specializing in complex biologics. The company serves over 500 client partners and has supported the advancement of more than 160 drug candidates from preclinical stages to market, including the manufacture of ten commercial products. KBI's comprehensive service portfolio includes cell line development, process development, analytical services, formulation development, and clinical and commercial cGMP manufacturing for both mammalian and microbial programs. With strategically located facilities across the United States and Europe, KBI leverages world-class analytical capabilities and proprietary platforms like SUREtechnology™ and PUREplatform™ to deliver personalized, accelerated solutions for biopharmaceutical development. The company is recognized for its scientific excellence, quality manufacturing, and commitment to helping clients bring innovative medicines to patients faster.