Principal Specialist – Quality Validation

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the quality of IT Validation & Compliance infrastructure within a Contract Development and Manufacturing Organization (CDMO) environment.

• Evaluate and authorize deliverables related to the enterprise software validation lifecycle.

• Provide comprehensive global oversight for enterprise software validation processes.

• Review and sanction changes to enterprise software, as well as CAPAs and deviations.

• Assist with the global data integrity initiative.

• Offer strategic and technical insights on global software validation issues.

• Ensure adherence to cGMPs, legal and regulatory obligations, as well as KBI internal standards.

⛳️ Requirements

• Bachelor’s degree and over 8 years of experience, or a Master’s degree with more than 6 years of experience in a QA or GMP setting, or equivalent qualifications.

• Proficient in Data Integrity, computer system validation, and IT quality within an FDA-regulated manufacturing context.

• Proven expert knowledge of 21 CFR Part 11 and/or EU Annex 11 regulations.

• Capable of reading, analyzing, and interpreting business publications, professional journals, technical procedures, and government regulations.

• Skilled in writing reports, business correspondence, and procedural documentation.

• Proficient in presenting information and addressing inquiries from staff, colleagues, managers, and clients.

• Able to read, analyze, and create complex documents.

• Capable of solving practical problems with minimal standardization.

• Competent in interpreting written, oral, diagrammatic, or schedule-based instructions.

🏝️ Benefits

• EEO/AA employer dedicated to promoting workforce diversity.

• Approximately 10% of travel required, both domestically and internationally.