QA Manager – Biotech Compliance & Quality Leadership

Amgen SA; Breda; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Bonus structure

13th month

Holiday allowance

Health insurance

On-site gym

Job summary

Amgen Breda is seeking a Manager QA to lead the Quality team supporting production shifts and ensure compliance with quality standards. You will guide Production, Maintenance & Engineering, and Quality staff, review cGMP records, and participate in audits and regulatory inspections.

The role emphasizes problem-solving, staff development, and collaboration to drive Lean improvements and batch disposition efficiency. A Master in Pharmacy with GMP experience is required.

Qualifications

• Master degree in Pharmacy or equivalent with GMP experience.
• 2+ years in GMP manufacturing and QA operations.
• Experience in audits and regulatory inspections.
• Strong problem-solving and scientific decision-making.

Responsibilities

• Lead QA staff supporting production shifts.
• Provide guidance to Production, Maintenance & Engineering, and Quality teams.
• Review cGMP records ensuring documentation compliance.
• Lead internal audits and participate in regulatory inspections.
• Drive Lean Transformation and continuous improvement initiatives.
• Train staff to perform required functions.
• Collaborate with operations to resolve quality issues.

Skills

Team leadership

GMP/QA experience

Regulatory knowledge

Quality investigations

Written communication

Education

Master in Pharmacy

Job description

Amgen Breda is seeking a Manager QA to lead the Quality team supporting production shifts and ensure compliance with quality standards. You will guide Production, Maintenance & Engineering, and Quality staff, review cGMP records, and participate in audits and regulatory inspections.

The role emphasizes problem-solving, staff development, and collaboration to drive Lean improvements and batch disposition efficiency. A Master in Pharmacy with GMP experience is required.