Quality Site Leader - Senior Director, GMP & QA Excellence

KBI Biopharma, Inc.; Durham (NC); On-site; USD 205,000 - 283,000; Full time

Benefits offered by this job

Not specified

Job summary

KBI Biopharma, Inc. is seeking a Senior Director of Quality, Quality Site Head to lead QA and QC at a microbial/mammalian production site. You will oversee raw material release, on‑the‑floor quality, data integrity, and regulatory inspections, while partnering with site leadership to drive GMP compliance and continuous improvement.

You will mentor and grow the QA/QC teams, manage deviations, CAPA, and ensure quality systems meet client and regulatory expectations across manufacturing and testing.

Qualifications

• Bachelor's degree in a scientific discipline with quality management experience.
• Master’s or PhD with extended quality experience is preferred.
• 15+ years in regulated pharmaceutical industry and cGMP know‑how.

Responsibilities

• Oversee quality systems, standards, and procedures for manufactured products.
• Ensure site is inspection ready and collaborates on continuous improvement.
• Lead and develop QA/QC teams and manage regulatory inspections.
• Drive risk management, CAPA, deviation handling, and data integrity.

Skills

Quality management

Regulatory inspections

Leadership

cGMP knowledge

Data integrity

Problem solving

Education

Bachelor of Science in a scientific discipline

Master’s degree in relevant field

PhD in relevant field

Tools

PowerPoint

Outlook

Excel

Job description

KBI Biopharma, Inc. is seeking a Senior Director of Quality, Quality Site Head to lead QA and QC at a microbial/mammalian production site. You will oversee raw material release, on‑the‑floor quality, data integrity, and regulatory inspections, while partnering with site leadership to drive GMP compliance and continuous improvement.

You will mentor and grow the QA/QC teams, manage deviations, CAPA, and ensure quality systems meet client and regulatory expectations across manufacturing and testing.