If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

　　SPECIALIST QA / QP (CLINICAL)

　　At Amgen Breda innovative and breakthrough investigational medicines are labeled, assembled, packaged, stored, and eventually shipped to various countries worldwide. Every day more than 1000 people from 40+ 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

　　In this role as Clinical Specialist QA / QP you will provide QA oversight and fulfil QP responsibilities for Investigational Medicinal Products received, labeled, packaged and distributed from the Amgen Breda facility, to various countries worldwide. You also provide guidance and support to the clinical production area, where approximately 50% of the global volume is packaged. It will be your task to ensure that quality operations, including clinical product release, are efficient and effective from both a compliance and business perspective. The goal is to establish and maintain effective working relationships with key partners, including Clinical Supply Chain, Production and Warehouse/Distribution staff, Study Management, and Regulatory Affairs.

　　Let’s do this. Let’s change the world. In this vital role, you will:

　　Perform batch certification of Investigational Medicinal Products in compliance with EU and international regulations.

　　Guide, coach and advice Clinical Supply Chain, Production, and Warehouse/Distribution staff regarding compliance with regulations and procedures (GMP and GDP).

　　Work closely with Supply Chain, Study Management and Regulatory Affairs, ensuring clinical trial designs can be supported effectively and compliantly from a supply perspective.

　　Lead and assist in quality investigations, approve deviations and corrective actions/ preventative actions (CAPA’s), lead and/or participate in audits and inspections.

　　Act as Quality representative for clinical changes, improvement initiatives and new product introductions and/or product variations.

　　Lead site and/or global projects and improvement efforts.

　　Review and sign QP to QP agreements, QP declarations, and Quality agreements

　　Act as delegate for the Sr. Manager Clinical QA in his/her absence

　　WIN

　　What we expect of you

　　We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an effective communicator with these qualifications:

　　Master’s in science in Pharmacy or Life Sciences, eligible as Qualified Person

　　Minimum of 5 years experience in the (clinical) pharmaceutical or medical device industry or typically 3+ years in Quality Assurance

　　Strong knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

　　Demonstrated experience in investigations, change control, validation, and/ or audits

　　Fluent in English

　　Preferred Requirements

　　Customer-oriented and service-minded.

　　Experience in manufacturing processes and operations of investigational medicinal products

　　Experience in (bio)pharmaceutical supply chain management, especially cold chain management

　　Knowledge of Good Clinical Practice (GCP)

　　Knowledge in Quality Management Systems applicable to the pharmaceutical industry.

　　Track record of success in international working environment

　　Project management experience

　　Expertise in the application of lean manufacturing principles and risk management

　　THRIVE

　　What you can expect of us

　　As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

　　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 a collective health insurance.

　　Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.