Manager Quality - International & Distribution Quality (IDQ)

Amgen

Breda, Netherlands

What you will do

The International & Distribution Quality (IDQ) team is looking for an experienced Quality Manager to support a diverse portfolio of regional activities across Europe.

In this vital role, you will provide Quality leadership and oversight across IDQ operations, ensuring compliant distribution of pharmaceutical products in line with Good Distribution Practices (GDP) across the EMEA region.

Let’s do this. Let’s change the world.

In this vital role you will:

Provide Quality oversight for storage, transportation and distribution activities, ensuring compliance with GDP, GMP and applicable pharmaceutical regulations
Oversee and continuously improve the Quality Management System (QMS) for IDQ operations
Act as Responsible Person (RP) or RP Back‑up, maintaining full regulatory compliance and reporting quality matters to senior management
Review, manage and approve Quality records including Deviations, CAPAs, CAPA EVs, Change Controls and Continuous Improvement initiatives
Support and participate in audits, self‑inspections and Health Authority inspections
Act as owner or Quality contact for deviation and CAPA records within Quality and Supply Chain
Track and ensure timely completion of Quality‑owned records
Provide Quality review and approval of controlled documents owned by Supply Chain
Assess and support planned changes, including product launches and record retirement, partnering closely with Country Responsible Persons to ensure regulatory compliance
Provide Quality oversight and ownership of continuous improvement programs and strategic projects within Quality and Supply Chain
Identify, escalate and communicate quality, compliance, supply and safety risks to senior management and support recall activities where required
Deliver training, awareness sessions and guidance to Quality and Supply Chain stakeholders to promote procedural compliance and quality culture
Work collaboratively and cross‑functionally with internal and external stakeholders, ensuring pharmaceutical products are distributed safely, compliantly and to the highest quality standards.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek brings:

In‑depth knowledge of European Pharmaceutical legislation, including:
- Good Distribution Practice (GDP)
- Good Manufacturing Practice (GMP)
- Falsified Medicines Directive
Role of the European Medicines Agency (EMA) and Country Health Authorities
Life Sciences degree or related discipline
Relevant experience in Quality and/or Supply Chain within a regulated pharmaceutical environment
Fluency in English
Strong organizational skills with the ability to multitask and prioritize effectively
High attention to detail and accuracy
Experience working with Quality Management Systems (QMS), ERP systems and Microsoft Office
Confidence working in a complex, matrixed and international environment