Senior Manager, Technical & Incoming Quality

Amgen; Breda; On-site; EUR 120,000 - 170,000; Full time

Job summary

Amgen Breda is seeking a Senior Manager of Quality (Technical and Incoming QA) to lead the Technical Quality and Incoming Quality teams. The role oversees CQV activities, validation and data integrity, ensuring compliance with EU GMP and GDP across manufacturing and packaging.

Strong leadership, regulatory experience and a commitment to patient safety are essential. The position requires a Master’s degree in a relevant science, 10+ years QA experience and at least 5 years of people leadership.

Qualifications

• Master’s degree in Pharmacy, Life Sciences, Engineering or equivalent.

Responsibilities

• Provide independent oversight of commissioning, qualification and validation (CQV) activities for facilities, equipment and packaging
• Oversee computerized system validation and data-integrity controls
• Ensure compliance with EU GMP, GDP and regulatory requirements for manufacturing and packaging
• Lead Technical Quality and Incoming Quality teams; drive quality governance and risk management
• Prepare for and participate in regulatory inspections and audits; drive timely responses to observations
• Define and track quality metrics and drive continuous improvement across QA functions
• Collaborate with cross-functional partners to balance patient safety, compliance and supply continuity

Skills

Quality leadership

Regulatory knowledge

People management

Problem solving

Communication

Education

Master's degree in Pharmacy/Life Sciences/Engineering

Tools

Quality systems knowledge

CQV principles

Job description

Amgen Breda is seeking a Senior Manager of Quality (Technical and Incoming QA) to lead the Technical Quality and Incoming Quality teams. The role oversees CQV activities, validation and data integrity, ensuring compliance with EU GMP and GDP across manufacturing and packaging.

Strong leadership, regulatory experience and a commitment to patient safety are essential. The position requires a Master’s degree in a relevant science, 10+ years QA experience and at least 5 years of people leadership.