Senior Supplier Quality Specialist — GMP & Audits

AGC Biologics A/S; København; Sur place; DKK 700 000 - 850 000; Plein temps

Avantages offerts par ce poste

International development opportunity

Cross-functional collaboration

Pension and health insurance

Training and development

Work-life balance

Copenhagen area activities

Résumé du poste

AGC Biologics A/S in Søborg is seeking a Supplier Quality Management Specialist to join the Quality Systems team. You will manage supplier qualifications, assessments and audits, develop Quality Agreements and support client audits and regulatory inspections.

A pragmatic, detail‑oriented mindset and strong writing and communication skills are essential. With a Master’s degree in pharmacy or life sciences and at least two years in biotech/pharma, you will collaborate across Material Science,

Qualifications

• Minimum 2 years prior working experience in a Biotech/Pharmaceutical environment, with a focus on supplier quality.
• Strong knowledge of GMP guidelines and international regulations for biopharmaceuticals.
• Proven technical writing skills and ability to communicate complex topics clearly.
• Experience with supplier qualification, audits and supplier quality agreements.

Responsabilités

• Participate in supplier qualification, assessments and ongoing performance evaluations.
• Support planning and execution of supplier audits; lead audits if trained/certified.
• Prepare, review, negotiate and maintain Supplier Quality Agreements.
• Support client audits and regulatory inspections as SME on supplier quality.
• Collaborate with Material Science, Quality Control and Supply Chain Management.
• Contribute to continuous improvement of supplier quality processes.

Connaissances

Attention to detail

Pragmatic mindset

Technical writing

Verbal communication

Time and priority management

Collaborative work

Formation

Master’s degree in pharmacy / biochemistry / life sciences

Description du poste

AGC Biologics A/S in Søborg is seeking a Supplier Quality Management Specialist to join the Quality Systems team. You will manage supplier qualifications, assessments and audits, develop Quality Agreements and support client audits and regulatory inspections.

A pragmatic, detail‑oriented mindset and strong writing and communication skills are essential. With a Master’s degree in pharmacy or life sciences and at least two years in biotech/pharma, you will collaborate across Material Science,