Global Supplier Quality Specialist — GMP & Audits

AGC Biologics; København; On-site; DKK 700,000 - 900,000; Full time

Benefits offered by this job

International work environment

Competitive compensation & benefits

Pension and health insurance

Training and development opportunities

Copenhagen-area employee activities

Job summary

AGC Biologics is seeking a Supplier Quality Management Specialist to strengthen our SQM team at the Søborg site. You will handle supplier qualifications, assessments, audits and quality agreements, while supporting client audits and regulatory inspections.

The role requires collaboration across Quality Systems and other functions to ensure GMP-compliant supplier performance. You will join a small team with room to develop into a Senior Specialist level depending on experience, and you will

Qualifications

• Minimum 2 years prior working experience in a Biotech/Pharmaceutical environment, with a focus on supplier quality.
• Master’s degree in pharmacy, biochemistry, or related life sciences field.
• Strong knowledge of GMP guidelines and international regulations pertaining to biopharmaceutical production (21 CFR Parts 11, 210, 211, 600, 610; EU GMP Parts I–III; ICH guidelines).
• Experienced lead auditor is an advantage but not required.

Responsibilities

• Participate in supplier qualification, assessments and continuous performance evaluations to ensure quality requirements are met.
• Support planning, preparation and execution of supplier audits; lead auditor training/development can be part of your growth plan.
• Prepare, review, negotiate and maintain Supplier Quality Agreements with internal/external partners.
• Act as subject matter expert on supplier quality during client audits and regulatory inspections.
• Collaborate with Material Science, Quality Control, Supply Chain Management and other functions at the site and AGC’s global network.
• Contribute to development and improvement of supplier quality processes and the site’s quality management system.

Skills

Detail-oriented

Technical writing

Verbal communication

Time management

Collaboration

Education

Master’s degree in pharmacy, biochemistry, or life sciences

Job description

AGC Biologics is seeking a Supplier Quality Management Specialist to strengthen our SQM team at the Søborg site. You will handle supplier qualifications, assessments, audits and quality agreements, while supporting client audits and regulatory inspections.

The role requires collaboration across Quality Systems and other functions to ensure GMP-compliant supplier performance. You will join a small team with room to develop into a Senior Specialist level depending on experience, and you will