Manager Quality – International & Distribution Quality (IDQ)

Career Category

Job Description

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us as:

Manager Quality International & Distribution Quality (IDQ)

At Amgen Breda medicines are labelled assembled stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes manufacturing marketing and sales of our medicines and clinical research into new medicines.

Live

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.

Lets do this. Lets 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 Backup 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 selfinspections 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 Qualityowned 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 crossfunctionally with internal and external stakeholders ensuring pharmaceutical products are distributed safely compliantly and to the highest quality standards.

Win

What we expect of you

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

• Indepth 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others we work to care for our teammates professional and personal growth and well-being. Therefore Amgen is regularly recognized as a Best Place To Work .

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary bonus structure fixed 13th month holiday allowance and collective health insurance.
• Focus on vitality with an on-site gym vitality program and a restaurant with healthy food.