QA Project Specialist

Are you looking for a place to feed your enthusiasm for quality? Are you excited about playing a crucial role in ensuring quality processes in Novo Nordisk’s global network of Contract Manufacturer Organisations (CMOs)? 

Then you can look forward to a leading role where your efforts can make a positive and direct difference every day, apply now to become our new QA Project Specialist!

The Position

In this position you will be the QA in project transfers from Novo Nordisk to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. 

Main responsibilities include:
• Quality responsibility for the technical transfer to the CMOs 
• Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
• 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 CAPAs

Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation. 

Expected travel is around 20 days a year as the CMOs are located outside Denmark primarily Europe and US. 

You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. 

Qualifications

To succeed in this role, you:

• hold an academic degree as Pharmacist, Engineer or similar 
• have a minumum 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
 
It is an advantage if you have extensive knowledge within Drug Products and Finished 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 humour to our department.

Finally, you meet own deadlines and know how to prioritise between different tasks in an everchanging environment.

About the Department

Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide.

GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs. 
We focus on good social relations and prioritise to make room for fun at work.