Principal Specialist - Quality Validation

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

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:
• 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.