QA Manager – Biotech Manufacturing & Compliance

Amgen; Breda; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Global mobility opportunities

Diversity and inclusion

Generous total rewards

On-site gym and restaurant

Job summary

Amgen Breda is seeking a Manager QA to lead the Quality team, directing QA staff and ensuring GMP-compliant production and documentation. The role involves guiding cross-functional partners and driving continuous improvement in quality systems.

The position requires a Master in Science in Pharmacy or equivalent and 2+ years of GMP/QA experience, with potential exposure to Qualified Person responsibilities. Amgen offers a diverse, global team and growth opportunities.

Qualifications

• Master degree in Pharmacy or equivalent; advanced GMP experience ok.
• Typically 2+ years of related GMP/QA experience in pharma manufacturing.

Responsibilities

• Lead and direct QA staff supporting production shifts.
• Provide guidance to Production, Maintenance & Engineering, and Quality staff on compliance.
• Review and approve cGMP records ( Deviations, CAPA, batch records) for compliance.
• Lead internal audits and participate in regulatory inspections and partner audits.
• Provide real-time QA oversight and support for production operations.
• Drive Lean Transformation and Operational Excellence initiatives in Plant QA.
• Train staff to perform their roles effectively and safely.
• Coordinate batch disposition interactions with PQA QP teams.

Skills

Problem solving

Communication skills

Education

Master in Science in Pharmacy or equivalent

Job description

Amgen Breda is seeking a Manager QA to lead the Quality team, directing QA staff and ensuring GMP-compliant production and documentation. The role involves guiding cross-functional partners and driving continuous improvement in quality systems.

The position requires a Master in Science in Pharmacy or equivalent and 2+ years of GMP/QA experience, with potential exposure to Qualified Person responsibilities. Amgen offers a diverse, global team and growth opportunities.