Senior QA Lead – GMP Compliance & Lab Oversight

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Principal QA Specialist to lead compliance reviews of GMP data across in-process, release, and stability testing.

You will oversee analytical and microbial workflows, validate methods, and support audits and regulatory inspections to ensure patient safety and product quality. You will mentor QA staff, coordinate with manufacturing, laboratories and clients, and drive quality systems improvements while maintaining cGMP standards in a fast-paced

Qualifications

• Bachelor’s degree and 10+ years’ experience or Master’s degree and 6+ years’ experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent.
• Strong understanding of FDA, EU and cGMP regulations is required.
• Ability to read, analyze, and interpret general business regulations and write reports.

Responsibilities

• Performs timely review of test data for in process, release, and stability samples.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities.
• Supports client audits and regulatory inspections as required.

Skills

FDA regulations

cGMP

Quality systems

Interpersonal skills

Attention to detail

Problem solving

Education

Bachelor's degree

Master's degree

Tools

Microsoft Office

LIMS

Teams

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Principal QA Specialist to lead compliance reviews of GMP data across in-process, release, and stability testing.

You will oversee analytical and microbial workflows, validate methods, and support audits and regulatory inspections to ensure patient safety and product quality. You will mentor QA staff, coordinate with manufacturing, laboratories and clients, and drive quality systems improvements while maintaining cGMP standards in a fast-paced