Impactful Quality Leader: Technical & Incoming QA

Amgen SA

Breda

On-site

EUR 120,000 - 170,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

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 commissioning, qualification and validation activities, including computerized system validation and packaging qualification, ensuring GMP, GDP, and regulatory compliance for manufacturing materials.

You will guide quality decisions, drive improvements, and prepare for regulatory inspections while partnering with cross-functional teams to protect

Qualifications

Master's degree in Pharmacy, Life Sciences, Engineering or related field.
Strong knowledge of EU GMP and global regulatory requirements.
Fluent written and spoken English.
10+ years of QA experience in pharma/biotech/medical-device.
5+ years of people leadership experience.

Responsibilities

Lead Technical Quality and Incoming Quality teams and oversee CQV activities.
Ensure validation, packaging qualification, data integrity, and release of materials.
Provide independent quality oversight of commissioning activities and CQV.
Prepare for and lead regulatory inspections; manage quality metrics and improvements.
Collaborate with cross-functional partners on quality decisions and risk management.