Senior Quality System Process Manager

Are you passionate about quality system compliance in highly regulated environments while working across multiple global departments?

We are seeking a skilled and experienced Senior Quality System Process Manager to join Global Quality where we are 25 dedicated employees. The position focuses on ensuring governance, maintenance and compliance of ALKs Quality System across a GxP-regulated environment.

The position

As the Senior Quality System Process Manager, you will be working with:

Operational tasks:

• Oversee ALKs Quality System and drive governance, maintenance and ensure compliance to regulations
• Drive and ensure implementation of new regulatory requirements from EU and FDA in the Quality Processes throughout ALK.
• Owner of the Quality Risk Management Process including implementation throughout ALK. Actively participate in designing, preparing, implementing, and continuously improving quality processes e.g. Training management, Change Management, Deviation handling, Document Management
• Provide QA expertise and support related to the ALK Quality System with a proactive approach.
• Provide training to stakeholders in ALKs Quality System and quality processes.
• Prepare and handle Change Controls, Deviations, and CAPAs within the Global Quality area.
• Prepare and review SOPs/WINs within the Global Quality area.
• Approve SOPs/WINs, documents and records supporting the organization.
• Facilitate Global cross functional process networks e.g. Quality Risk Management, Training management, Annual Product Quality Review.

Project Participation:

• Participate in Global Quality improvement initiatives to enhance efficient quality processes and linked IT systems including implementation of future systems and automated processes.

Your profile

We expect that:

• You hold an academic degree in life science, engineering, or related field.
• You have at least 7 years of experience from the pharmaceutical or medical device industry and have experience with EU GMP, ICH Q9/Q10, FDA 21 CFR 210/211, MDR and/or other GxP regulated areas.
• You have extensive hands-on experience with governance and improvement of quality systems and quality processes. Experience with Quality Risk Management will be an advantage.
• You have a proven ability to manage complex initiatives, prioritize, and deliver on time in a regulated setting.

Your personal characteristics:

• Possess high drive and you take initiative and proactive action.
• Ability to work independently but also being a team player.

• Relation builder working respectfully across different cultures with flexibility.
• You have solid cross-cultural communication skills who excel both verbally and written in English and Danish.

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 specializing in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues. You will report to Senior Director, Global Business Operations and be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organization, 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.