Amgen Senior Manager Supply Chain Compliance in Breda, Netherlands
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:
Senior Manager Supply Chain Compliance
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.
What you will do
The Senior Manager Supply Chain Compliance will be responsible for the compliance activities related to the EMEA region supply chain including leading a team of staff performing the activities in the field of compliance, quality and SOX processes. Do you have the capabilities to embed the principles of Good Distribution Practices guideline (2013/C 343/01) and the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the quality and authenticity of the Amgen products is maintained? Furthermore, you will ensure compliance to the financial SOX processes across the EMEA region.
Let’s do this. Let’s change the world. In this vital role you will:
Ensure that processes and procedures within the region fulfill the requirements of GDP and FMD.
Provide guidance and direction in all areas of GDP, FMD and SOX compliance to the other functions within EMEA.
Lead EMEA Compliance Supply Chain team.
Be responsible for the successful use of the following quality systems: Deviation, CAPA, CAPA Effectiveness, Temperature Excursions and Distribution Complaints. Report and defend these during the Management Review meetings.
Ensure audit and inspection readiness and SOX compliance for the EMEA Supply Chain
Lead and participate in audits and inspections involving EU supply chain, including audits and inspections at the affiliate level.
Ensure that actions resulting from audits and inspections are adequately addressed and followed up.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek is a strong leader with these qualifications:
Master’s degree or equivalent in Life Sciences or Logistics + 3 years’ experience in pharmaceutical distribution
Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
Fluency in English and Dutch (preferable)
Good understanding of SOX processes
Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Trackwise, EDMQ, etc)
Effective communicator, strong leader, analytical and pro-active.
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 recognized as World's Best Workplace 2021 (ranking: #8).
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.