QA Manager: Lead Quality & Compliance in Biotech

Amgen Inc. (IR); Breda; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen Breda is seeking a Manager QA to lead the Quality team supporting production, ensure compliance with GMP standards, and guide cross-functional staff including Maintenance and Engineering. This role includes oversight of batch records, CAPAs, deviations, and continuous improvement initiatives.

The successful candidate will have a Master in Science in Pharmacy or a related Master’s with GMP experience, plus 2+ years in GMP environments, and strong problem-solving and communication skills.

Qualifications

• Master in Science degree in Pharmacy or equivalent; or any other Master’s degree with GMP experience.
• Typically 2+ years of related professional experience in GMP manufacturing, warehousing, supply chain, equipment engineering and validation.
• Optional: Qualified Person under EU directive 2001/83/EC; not mandatory.
• Ability to problem solve and make scientific risk-based decisions.
• Strong written and verbal communication skills with the ability to communicate effectively with production and technical staff.

Responsibilities

• Lead and direct Quality staff supporting production in the shift.
• Provide guidance to Production, Maintenance & Engineering, and Quality staff regarding compliance with quality standards and procedures.
• Manage resource planning (e.g. shift roster, holidays) per business need.
• Responsible for achieving Plant QA KPIs.
• Provide real-time QA oversight and support for production operations.
• Collaborate with operations to resolve quality and compliance issues.
• Lead investigations as needed and participate in internal audits and regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives within Plant QA.
• Train staff to perform their functions.
• Understand batch review activities and align with PQA QP’s to enable batch disposition within timelines.

Skills

Problem solving

Written and verbal communication

Team leadership

Education

Master in Science in Pharmacy

Master’s degree with GMP experience

Job description

Amgen Breda is seeking a Manager QA to lead the Quality team supporting production, ensure compliance with GMP standards, and guide cross-functional staff including Maintenance and Engineering. This role includes oversight of batch records, CAPAs, deviations, and continuous improvement initiatives.

The successful candidate will have a Master in Science in Pharmacy or a related Master’s with GMP experience, plus 2+ years in GMP environments, and strong problem-solving and communication skills.