Specialist Quality Assurance / Qualified Person (Clinical)

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 Quality Assurance / Qualified Person (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 unique role as Qualified Person in our Clinical Quality Assurance department you will have the opportunity to gain broad experience within QA. You will provide QA oversight and fulfill QP responsibilities for Investigational Medicinal Products received, labeled, packaged, and distributed from the Amgen Breda facility to various countries worldwide. 

For the clinical production area, where approximately 50% of the global volume is packaged, it will be your task to ensure a high level of quality operations. As a Qualified Person, you will be the expert in releasing clinical product batches and ensuring efficiency and compliance throughout the process.

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 advise 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), and 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 a 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

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