Global Process Owner in QA

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Would you like to be the manager of quality processes and help us improve the lives of people with intimate health care needs? Then consider applying for this job where you will work with local process owners and stakeholders in our headquarters as well as colleagues from production sites around the world

The role as Global Process Owner is vital. Our license to sell relies, among other things, on our ability to monitor and improve the quality processes, to make sure we meet regulatory requirements. If we cannot ensure this, at the end of the day we will not be able to live up to our goal of making life easier for people with personal medical conditions.

Join our Quality Process department
In joining us, you will be part of a small department of 10 colleagues, of which two are Global Process Owners for the global quality processes Complaints and CAPA&NC, while the rest are GPOs and Business Application Specialists for other processes. Together we are responsible for bringing expert knowledge on core quality processes into the entire Coloplast organisation, from innovation projects to production value streams, distribution centres and supply chain, meaning we have broad contact with many different stakeholders.

You support, deploy, and develop
Your main task as our Global Process Owner for Change Control and Internal Audit is to be responsible for continuously supporting and developing these processes.

In this role you will:

• Guide and collaborate with the Local Process Owners (LPO) appointed by production sites in Hungary, China, US, France, Sweeden, Germany and Costa Rica to ensure they deploy process updates and stay compliant with training.
• Identify gaps and collect, analyse, and facilitate improvement ideas.
• Train and develop local process owners at global sites and in our headquarters in Humlebæk for the processes you own.
• Support LPOs and other important stakeholders with ad hoc support.
• Monitor, document, and improve the processes so they comply and align with stakeholder and customer needs – a keen eye for compliance and practical implementation is a must to succeed with this.
• Request updates to the IT quality platform (Veeva) to assure needed process updates.
• Manage data analysis and KPI reporting to management review and other relevant stakeholders.
• Provide tools to ensure and document that all elements of the QMS are audited.
• Be responsible for the audit program in headquarters in Humlebæk and pilot plant in Mørdrup.

You set directions while understanding the environment in which you operate
For this position your ability to work with process details while setting the direction at a strategic level is key. Stakeholder management and communicating with people at many different levels and functions are strong competences of yours, and understanding the global and local environment in which the Quality Processes are embedded motivates and energizes you. You can maintain transparency and a clear picture of the practical functionality of the processes and your capability to establish strong links between compliance and the daily use of the processes is therefore of great importance.

You are skilled in communicating across cultures
This global role is based in our headquarters in Humlebæk, and you will be working with numerous colleagues near and far. Travel is limited to max 10 days per year as we mainly work with our global sites through the local process owners. Here your proficiency as a skilled cross-cultural facilitator and communicator is important, as you are dependent on local process owner feedback to succeed.

You:

• Hold minimum 5+ years of experience, where you have worked with quality processes, preferably from a quality/strategic function or as a project manager.
• Are a trained auditor and have 5+ years of experience conducting internal audits.
• Bring a proven track record of processing and analysing data and using it proactively.
• Have experience with Lean tools to map, manage, and optimise processes.
• Have experience with stakeholder management globally.
• Speak and write English effortlessly.

Interested?
If you would like to know more about the position, please write to Head of Post Market Surveillance, Systems and Processes, Lotte Dock Steenstrup at [email protected]. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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