Senior QA Lead - Facilities, Validation & Compliance

KBI Biopharma; North Carolina; On-site; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior QA Specialist to provide QA oversight across GMP facilities, validation, cleaning validation, metrology and computerized systems in support of clinical and commercial manufacturing operations.

The role partners with Engineering, Facilities, Validation, MSAT, IT, and other cross-functional teams to ensure facilities, utilities, equipment and validated processes stay compliant and in a state of control throughout their lifecycle.

Qualifications

• Experience reviewing change controls, deviations, investigations, and CAPAs.
• Familiarity with US/EU cGMP regulations and guidelines.
• Experience in QA oversight of GMP facilities and validation activities.
• Ability to manage multiple priorities in a fast-paced setting.

Responsibilities

• Provide QA oversight for GMP facilities, utilities, equipment, validation, and systems.
• Review and approve GMP documentation including qualification, validation, deviations, CAPAs, change controls.
• Oversee commissioning, qualification, and validation activities and lifecycle management.
• Support regulatory inspections, audits, and readiness activities.
• Identify and mitigate quality risks with cross-functional teams.
• Support continuous improvement of QA processes.

Skills

QA oversight

cGMP knowledge

Regulatory knowledge (US/EU)

Cross-functional collaboration

Problem-solving

Technical writing

Education

Bachelor’s/Master’s degree in related field

Job description

KBI Biopharma, Inc. is seeking a Senior QA Specialist to provide QA oversight across GMP facilities, validation, cleaning validation, metrology and computerized systems in support of clinical and commercial manufacturing operations.

The role partners with Engineering, Facilities, Validation, MSAT, IT, and other cross-functional teams to ensure facilities, utilities, equipment and validated processes stay compliant and in a state of control throughout their lifecycle.