Clinical Compliance Manager

Short intro

Would you like to make an impact on improving the quality of life of millions suffering from allergic diseases? Do you have a Quality mindset and thrive in optimisation of processes?

The position

In a constantly evolving regulatory framework ALK is seeking an ambitious and dedicated person to fulfill this support role to maintain a high level of compliance with internal and external regulatory requirements.

You will be responsible for a wide range of tasks such as process optimisation and maintenance/support of our Standard Operating Procedures (SOPs) including deviations to these, Regulatory requirements review and Impact assessments, supporting regulatory inspections and internal audits, training and distribution of our Quality Documents, advice on regulatory guidelines, trending of quality parameters and reporting of these to Global Clinical Development (GCD) Management.

Your primary tasks will be:

• Act as compliance support to GCD.
• Provide relevant regulatory GCP advice and support.
• Support GCD with maintenance and continuous improvement of the Quality Management System (QMS).
• Act as project manager on relevant updates to the QMS and where relevant writing Quality Documents.
• Handle and process of deviations from GCD processes on a daily basis including escalation of trends.
• Handle of potential Serious breaches to GCP and individual protocols.
• Ensure that relevant Quality Documents are distributed to relevant staff via our electronic training module.
• Support ALK and GCD in internal audits and Health Authority inspections.
• Participate in cross-functional and/or function-area projects e.g. to implement new legislation/guidelines or other cross-functional tasks/projects.

Your profile

We expect that you have:

• B.Sc. within nature science or similar
• 4-5 years of experience within Clinical Development.
• A team player with good analytical skills and quality-oriented mindset.
• Ability to understand various stakeholder needs whilst maintaining objectivity.  

Become a part of ALK

We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply

Apply by attaching your CV and a short letter of motivation, no later than 01-Mar-2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Sanne Mathias, Associate Director, clinical Compliance & Processes, GCD mobile +4541959059.

We are looking forward to hearing from you!