Manager Incoming Quality

Manager Incoming Quality

Amgen

Breda, Netherlands

What you will do

In this vital role, you will lead the Incoming Quality Assurance (IQA) team in Breda, ensuring high standards of quality and compliance across incoming materials and processes. You will play a key role in shaping a strong quality culture while developing and empowering your team to perform at their best.

You will oversee the end-to-end Incoming Quality processes, ensuring they are executed efficiently, consistently, and in full compliance with GMP and regulatory requirements. At the same time, you will act as a key decision-maker within QA, bringing a risk-based mindset to quality-related topics.

Your main responsibilities will include:

• Leading, coaching, and developing the IQA team, including hiring and performance management
• Ensuring effective sampling, inspection, and disposition of incoming materials
• Reviewing and approving deviations, CAPAs, and change controls in line with quality standards
• Acting as Subject Matter Expert (SME) for Incoming Quality and driving continuous improvement initiatives
• Use of digital tools and technologies to analyse team performance and identifying most valuable improvements’

In addition, you will work closely with cross-functional stakeholders and contribute to broader quality and business objectives by:

• Supporting audits (internal and external) and ensuring inspection readiness
• Driving process improvements and participating in key projects and programs
• Collaborating with Supply Chain, Manufacturing, and Warehouse teams to ensure alignment and operational excellence

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The QA Manager we seek is a strong leader with the following qualifications:

Minimum Qualifications:

• Master’s degree in Pharmaceutical Sciences, Life Sciences, or equivalent
• +3 years of experience in a GMP-regulated environment
• Experience in people management
• Proven experience in investigations, CAPAs, and process improvement

Preferred Qualifications:

• Experience in the pharmaceutical industry
• Experience in supplier management
• Familiarity with deviations, CAPAs, and change control processes
• Knowledge of risk management tools (e.g., FMEA)

Key Competencies:

• Strong leadership and team development skills
• Effective communication across multiple stakeholders
• Analytical mindset with a risk-based approach
• Decision-making skills and ability to manage complexity
• Continuous improvement of mindset and interest in new technologies