Senior-Training-Compliance-Manager

Senior Training Compliance Manager

Do you enjoy working with QMS process alignment and optimization in a global organization? Would you like to set direction for Ambu’s Global QMS process for Training & Competence Development? Then this position may be your next exciting opportunity.

We are looking for a Senior Training Compliance Manager to take the role as global QMS process owner of Ambu’s process for Training & Competence development. You will join the Global Quality Management Systems department in Ballerup, with colleagues located in both Ballerup and Augsburg.

You will be part of a strong quality culture where Take Charge, Team Up and Stay True are our core values.

A global job with impact
As Senior Training Compliance Manager and QMS process owner of the global Training & Competence development process, you will get a varied working day in a dynamic organization. Your key responsibilities will be to:

• Be the global process owner of the QMS process for Training & Competence development.
• Be the Corporate subject matter expert of applicable external requirements for training and how to effectively implement these.
• Continuously maintain, develop, and improve the process in alignment with industry practices and in collaboration with the local quality organizations and training responsible from Ambu’s four manufacturing sites.
• Work closely with the global QMS process owner of Document Control and global Learning Management System responsible to improve the process of assigning R&U training through the electronic Learning Management System (SuccessFactors).
• Develop and provide training to support Ambu Ballerup and Augsburg line management in understanding their responsibilities related to training and competence development and provide day-to-day support.
• Take lead on supporting Ambu Ballerup and Augsburg line management in completion of yearly training review activities.
• Work with local training responsible across Ambu sites to align on requirements for training of line management and yearly training review expectations.
• Participate in Notified Body audits and inspections by authorities, presenting the QMS process.

Experience and passion
Skills and experiences can be gained in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have

• Relevant academic background, BSc / MSc
• At least 6-8 years’ experience of working within a quality organization for medical devices or pharmaceuticals.
• Demonstrated experience of working with / being responsible for the QMS process for training in a medical device or pharmaceutical company.
• In depth knowledge of requirements for training from relevant regulations for medical devices e.g., ISO13485, MDSAP
• Passion for quality and focus on business partnering with the organization.
• Knowledge of Agile system for document & change control and / or SuccessFactors Learning is an advantage.
• Lead auditor experience will be welcomed and provide the opportunity to perform internal & corporate audits in the Ambu organization.

As a person, you are outgoing, have a good business understanding and are confident in communicating quality requirements and facilitating effective implementation in an organization.

It is important that you are self-driven, like to take the lead, and that you can work independently. You take pride in good collaboration, and you are open-minded and see possibilities even when daily life is dynamic and hectic.

Ambu is a global company, and English is our corporate language, which requires that you speak and write English at a relatively high level.

Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office in an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.