Senior Quality Leader - Technical & Incoming QA

Amgen; Netherlands; On-site; EUR 110,000 - 150,000; Full time

Job summary

Amgen Breda is seeking a Senior Manager Quality (Technical and Incoming QA) to lead the Technical Quality and Incoming Quality teams. You will oversee CQV activities and ensure that facilities, equipment and packaging meet GMP, GDP and regulatory requirements.

In this role you will collaborate with Manufacturing, Warehouse, Supply Chain, Engineering and Validation to maintain compliance while supporting supply continuity.

Qualifications

• Education and experience in pharmaceutical quality management and compliance.
• Experience leading Quality teams and cross-functional collaboration.
• Strong knowledge of CQV, validation, and regulatory expectations.

Responsibilities

• Lead Technical Quality and Incoming Quality teams to deliver priorities.
• Provide independent oversight of CQV activities and validation.
• Ensure products and packaging meet GMP, GDP and regulatory requirements.
• Prepare for and participate in regulatory inspections and audits.
• Guide cross-functional partners on Quality decisions balancing compliance and supply continuity.

Skills

Quality leadership

CQV oversight

GMP/GDP knowledge

Regulatory compliance

Team leadership

Risk management

Education

Master's degree in Pharmacy, Life Sciences, Engineering

Tools

QMS software

Regulatory databases

Job description

Amgen Breda is seeking a Senior Manager Quality (Technical and Incoming QA) to lead the Technical Quality and Incoming Quality teams. You will oversee CQV activities and ensure that facilities, equipment and packaging meet GMP, GDP and regulatory requirements.

In this role you will collaborate with Manufacturing, Warehouse, Supply Chain, Engineering and Validation to maintain compliance while supporting supply continuity.