Senior QA Lead, Facilities & Compliance

KBI Biopharma, Inc.; Durham (NC); Hybrid; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Senior QA Specialist to provide QA oversight for Facilities, Engineering, Validation, Cleaning Validation, Metrology, and computerized systems throughout the lifecycle. You will review and approve GMP docs, support qualification activities, and lead QA involvement in change controls and CAPAs.

The role requires strong knowledge of US/EU cGMP, excellent technical judgment, and ability to manage multiple priorities in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree with 8+ years of relevant QA experience in a cGMP biopharmaceutical environment.
• Master's degree with 5+ years of relevant QA experience in a cGMP biopharmaceutical environment.
• Knowledge of US/EU cGMP regulations and guidelines is required.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, validation, cleaning validation, metrology, and computerized systems.
• Review and approve GMP documentation including qualification/validation protocols and change controls.
• Support commissioning, qualification, and validation activities including IQ/OQ/PQ and process validation.
• Assist investigations and CAPAs related to facilities, utilities, equipment, validation, and computerized systems.
• Support regulatory inspections, audits, and inspection readiness.

Skills

QA oversight

Risk-based decision making

Cross-functional collaboration

Technical writing

Problem solving

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

GxP documentation systems

Job description

KBI Biopharma, Inc. in Durham, NC seeks a Senior QA Specialist to provide QA oversight for Facilities, Engineering, Validation, Cleaning Validation, Metrology, and computerized systems throughout the lifecycle. You will review and approve GMP docs, support qualification activities, and lead QA involvement in change controls and CAPAs.

The role requires strong knowledge of US/EU cGMP, excellent technical judgment, and ability to manage multiple priorities in a fast-paced manufacturing environment.