QA Manager - Technical QA

Career Category

Quality

Job Description

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Technical QA Manager

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.

Live

What you will do

Let’s do this. Let’s change the world.

As the Technical QA Manger, you will lead the Technical Quality Assurance (TQA) team, driving quality excellence in technical projects, site operations and validation activities.

In this role you will:

• Manage, lead and motivate the TQA team, including hiring, coaching, capacity planning and performance management.
• Ensure robust QA oversight for validation of equipment, automation and information systems, guaranteeing compliance with Corporate, Site and Regulatory (GMP) requirements. Provide subject‑matter expertise in complex quality investigations and continuous improvement initiatives.
• Lead or support internal and external audits, acting as a key quality representative. Review and approve deviations, CAPAs, Change Controls and equipment‑related changes, ensuring quality and regulatory requirements are met.
• Guide validation and technical project strategies in collaboration with Process Development, Maintenance & Engineering, ATMOS and Manufacturing.
• Act as QA contact for technical change controls and ensure end‑to‑end compliance of all project documentation.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Technical QA Manager we seek is a strong leader with the following qualifications:

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent.
• Previous experience in a GMP environment, within the pharmaceutical industry.
• Minimum 1 year of people management experience.
• Demonstrated experience with equipment and automation/IS validation, computer compliance.
• Experience with risk management methodologies (e.g., FMEA).
• Proven project management capabilities.
• Experience with Nonconformances, CAPAs and Change Control.
• Experience with statistical tools supporting sampling plans or hypothesis testing.
• Strong leadership and coaching mindset.
• Excellent communication skills across functions and levels.
• Risk based decision making and strong analytical capabilities.
• High attention to detail and excellent writing skills.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is regularly recognized as a Best Place To Work ©.

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
• Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.

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