Biotech QA Leader: Quality Systems & Compliance

Bio Usawa; Time; On-site; NOK 1,049,000 - 1,430,000; Full time

Job summary

Bio Usawa Biotechnology is seeking a Head of Quality Assurance to lead the establishment and implementation of robust quality systems for monoclonal antibody manufacturing. The role requires extensive biopharmaceutical QA experience, regulatory expertise, and strategic leadership to build a quality culture from the ground up.

The ideal candidate will develop QMS, SOPs, and risk management frameworks, align with GMP and global regulatory expectations, and oversee cross-functional teams to ensure

Qualifications

• Advanced degree in biotechnology, biochemistry, or a related field is required.
• Minimum 10–12 years in biopharmaceutical quality assurance with leadership experience.
• Proven track record in GMP, regulatory inspections, and QA system implementation.

Responsibilities

• Lead design, development, and deployment of comprehensive quality management systems.
• Ensure regulatory compliance with GMP, ICH guidelines, and international standards.
• Oversee SOPs, CAPA, deviation management, and change control processes.
• Build and mentor a high-performing QA team across the organization.

Skills

Quality Assurance

QMS Development

Leadership

Regulatory Compliance

GMP Knowledge

Education

Advanced degree in Biotechnology or related field

Tools

QMS Software

Job description

Bio Usawa Biotechnology is seeking a Head of Quality Assurance to lead the establishment and implementation of robust quality systems for monoclonal antibody manufacturing. The role requires extensive biopharmaceutical QA experience, regulatory expertise, and strategic leadership to build a quality culture from the ground up.

The ideal candidate will develop QMS, SOPs, and risk management frameworks, align with GMP and global regulatory expectations, and oversee cross-functional teams to ensure