Principal Specialist - Quality Validation

KBI Biopharma, Inc.; North Carolina; Hybrid; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an IT Validation & Compliance professional to ensure the quality of enterprise software in our GMP CDMO environment.

The role reviews and approves validation lifecycle deliverables and oversees change controls, CAPAs, and deviations related to enterprise software. The ideal candidate provides strategic and technical expertise on global software validation, ensuring compliance with 21 CFR Part 11, EU Annex 11, and internal KBI requirements, with travel up to 10% to

Qualifications

• BS or MS with 6–8+ years in a QA or GMP environment.
• Experience with data integrity, computer system validation, and IT quality in FDA-regulated manufacturing.
• Expert knowledge of 21 CFR Part 11 and/or EU Annex 11.

Responsibilities

• Provide global oversight of enterprise software validation.
• Review and approve validation lifecycle deliverables for enterprise software projects.
• Review and approve enterprise software change controls, CAPAs, and deviations.
• Support data integrity global initiative.

Skills

Data Integrity

Computer System Validation

IT Quality

Regulatory Compliance

FDA Regulated Environment

Education

BS in QA/GMP

MS in QA/GMP

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.

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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.