QA Project Specialist LCMO

at  Novo Nordisk

QA Project Specialist LCMO
Category: Quality
Location:Søborg, Capital Region of Denmark, DK
Are you passionate about ensuring quality? Do you thrive on the opportunity to play a crucial role in Novo Nordisk’s global network of Local Contract Manufacturer Organizations (LCMOs)? Are you eager to contribute to projects that supply insulin to regions with limited access to this life-saving medication, such as South Africa, India, and other developing markets?
If so, we invite you to step into a leading role where your work will make a positive and direct impact every day. Apply now to become our new QA Project Specialist and join us in our mission to make insulin more accessible globally!

QUALIFICATIONS

To succeed in this role, you:

• hold an academic degree as Pharmacist, Engineer or similar
• have a minimum of 5 years’ experience from the pharmaceutical industry either from production or QA
• have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk
• are proficient in English and knowledge of other languages will be an advantage

It is an advantage if you have extensive knowledge within aseptic Drug Products.
On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humor to our department. Finally, you meet own deadlines and know how to prioritize between different tasks in an everchanging environment.

Main responsibilities include:

• Quality responsibility for the technical transfer to the CMOs in market and capacity expansion projects and be responsible for setting the quality and compliance direction
• Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
• You will promote good collaboration with the CMO as well as build the Quality mind-set and Compliance culture at the CMO, including activities such as to train the local CMO QA organization to maintain and improve compliant operation and to act as both coach and mentor at the CMO’s
• Negotiation and implementation of quality agreements, approving process validation strategy and related documents
• Setting up the QA processes for commercial manufacturing.
• Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPA

To succeed in this role, you:

• hold an academic degree as Pharmacist, Engineer or similar
• have a minimum of 5 years’ experience from the pharmaceutical industry either from production or QA
• have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing Novo Nordisk
• are proficient in English and knowledge of other languages will be an advantag