Specialist QA / QP

Career Category

Job Description

Building our Talent Pipeline for Specialist QA / QP

With this position, we want to prepare for future opportunities as a QP in the Site Quality team. Do you meet the qualifications and are you interested in exploring this opportunity?

At Amgen Breda, medicines are labeled, assembled, stored, and shipped to various countries worldwide. Every day, more than 1,000 people from 42 different nationalities work on supply chain processes, manufacturing, marketing, sales of our medicines, and clinical research into new treatments.

Specialist QA/ QP

LIVE

What you will do

Our Quality Assurance (QA) team plays a critical role in ensuring that our mission to serve patients is upheld by maintaining the highest standards of quality across all aspects of our products and processes. Whether it’s ensuring compliance during clinical research, overseeing production quality, or monitoring the supply chain, our QA professionals are central to Amgen’s success.

As a Specialist Quality Assurance/Qualified Person, you will ensure that our medicines meet rigorous quality standards and comply with regulatory requirements. You will also collaborate with cross-functional teams to uphold and improve quality systems, support innovation, and enhance patient care.

In this vital role, you will:

• Release products for various markets, ensuring compliance with regulatory and quality standards.
• Collaborate with production, supply chain, and engineering teams to establish and guide quality requirements.
• Own, review, and approve quality-related documentation (e.g., SOPs, Training, Risk Assessments).
• Assess and approve deviations, CAPAs, and change controls, taking ownership when required.
• Conduct impact assessments for changes affecting QA or production processes.
• Drive and contribute to continuous improvement and digital innovation initiatives.
• Support or lead internal audits and regulatory inspections.
• Provide training and guidance on GMP and quality-related topics.

WIN

What we expect of you

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

• Master’s degree in Science (mandatory).
• Experience in Quality Assurance within the pharmaceutical, biotechnology, or medical devices industry.
• Meets the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
• Strong knowledge of Good Manufacturing Practices (GMP).
• Demonstrated ability to make risk-based decisions and solve problems scientifically.
• Proficiency in written and verbal communication, including technical writing and collaboration with cross-functional teams.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, we are equally dedicated to the well-being and development of our team members. Amgen is regularly recognized as a Great Place To Work ©.

• Vast opportunities to learn and grow within our global organization.
• A diverse and inclusive environment where innovation is encouraged.
• A competitive Total Rewards Plan, including a salary, bonus structure, 13th month, holiday allowance, and collective health insurance.
• Focus on vitality with an on-site gym, a wellness program, and healthy food options