Quality Site Head — GMP Strategy & Compliance

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

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a Senior Director of Quality, Quality Site Head to lead QA and QC teams across microbial and mammalian production.

You will own raw material release, QA review of QC data, and compliance with cGMPs while partnering with global Quality and client teams. The role demands extensive quality management, regulatory inspections experience, and strategic leadership to drive continuous improvement and ensure site readiness for audits and manufacturing.

Qualifications

• Bachelor of Science degree in a scientific discipline with extensive quality management experience.
• Advanced degrees (Master's or PhD) are considered with commensurate quality experience.
• Minimum 15 years in regulated pharmaceutical industry with cGMP knowledge and biotech regulations.

Responsibilities

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product.
• Lead, mentor, and develop departmental associates and manage performance to meet objectives.
• Be a key contributor to long term strategic planning and senior leadership decisions.
• Collaborate with internal and client teams to define Quality strategy and solve problems.

Skills

Quality leadership

Regulatory inspections

Quality systems

Risk management

Cross-functional leadership

Education

Bachelor of Science in a scientific discipline

Master's degree

PhD

Job description

KBI Biopharma, Inc. in Durham, NC, seeks a Senior Director of Quality, Quality Site Head to lead QA and QC teams across microbial and mammalian production.

You will own raw material release, QA review of QC data, and compliance with cGMPs while partnering with global Quality and client teams. The role demands extensive quality management, regulatory inspections experience, and strategic leadership to drive continuous improvement and ensure site readiness for audits and manufacturing.