Sr Manager Plant Quality Assurance

Career Category

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:

Sr Manager Plant Quality Assurance

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 38 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

As Senior Manager Plant Quality Assurance you will lead our Shift Plant QA and Batch Release teams. With a team of highly qualified professionals under your guidance, you will ensure quality oversight of our manual and fully automated packaging lines. Striving for the highest quality and compliance, you’ll oversee timely release of our commercial medicines, ensuring we supply every patient every time!

We are looking for a skilled leader to join our Quality Management Team and to manage this team of 16 people (Manager Quality, Quality Specialists / Qualified Persons and Sr Associate Quality). Are you looking for a role with high visibility in the middle of our operational process? This might be the opportunity for you.

Let’s do this. Let’s change the world. In this vital role you will:

• Manage, lead and empower the Plant QA team to enhance performance to achieve business goals, agreed metrics and budgets.

• Steer the talent acquisition and succession planning strategies, fostering a skilled and motivated workforce.

• Ensure on time resolution of deviations and timely implementation of effective CAPAs. Lead and assist in various investigations as needed.

• Cultivate robust relationships with Production, Maintenance & Engineering, Supply Chain, and Warehouse/Distribution teams.

• Ensure daily adherence to GxP operations through meticulous implementation of Quality policies, procedures and programs.

• Partner with Production and Engineering to ensure compliance and perform risk analyses.

• Drive continuous improvement efforts locally and globally and play an integral role as a key member of the ABR Quality Management Team.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:

• Pharmacist Qualification or related education.

• At least 5 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits.

• At least 3 years of supervisory experience. Managing, coaching and developing a team.

• Deep understanding of Global Regulatory guidelines (Good Manufacturing Practice) with the ability to interpret and apply in both routine and non-routine cases.

• Extensive knowledge of manufacturing processes and operations.

• Extensive knowledge of GxP change control, investigations, validation and training requirements.

• Confident decision maker, effective communicator and driving for results.

• Fluent in English language

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. Amgen Europe B.V is certified as Great 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.

• Flexible work arrangement with days in the office and days from home.