Global Process Owner - Change Control & Internal Audit

Location: 

Humlebæk, DK

Job Family:  Quality Assurance
Country/Region:  Denmark
 

 

Would you like to manage quality processes and thereby help us improve the lives of people with intimate health care needs? Then consider applying for this job where you will work with colleagues from production sites around the world, and various departments in HQ. 

 

The position as a Global Process Owner is vital to Coloplast’s way of doing business. Our license to sell, relies, among other things, on our ability to monitor and improve the quality processes, to ensure 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, to make life easier for people with personal medical conditions. Therefore, you, as our GPO, play a major part in making this come true.

 

Join our Quality Process department
Joining us, you will be part of a department of 10 colleagues, of which two of them are Global Process Owners for other global quality processes (Complaints, CAPA and NC). Together, we are responsible for bringing expert knowledge on core quality processes into the entire Coloplast organisation, from innovation projects to production values streams, distribution centres, and supply chain.
 
You support, deploy, and develop
As our Global Process Owner for Change Control and Internal Audit, your main task is to be responsible for continuously supporting and developing these processes.

 

In this role you will:

  • Monitor, document and improve the processes so they are compliant and aligned with stakeholder and customer needs
  • Collaborate with production sites in Hungary, China, US, France, and Costa Rica to ensure that 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 headquarter in Humlebæk for the processes you own
  • Support LPOs and other important stakeholders with Ad Hoc support globally
  • Request updates to the IT quality platform to ensure needed processes updates
  • Manage data analysis, and reporting of KPIs to management review and stakeholders
  • Provide constant optimization of the processes you own, ensuring compliance with current regulations
  • Provide tools to ensure and document that all elements of the QMS are audited
  • Be responsible for the audit program in headquarter in Humlebæk and Pilot plan in Mørdrup

 

You set direction while understanding the environment in which you operate
Your ability to work with details but also set the direction at a strategic level is key for this position. Stakeholder management is a strong competence of yours and you are motivated and energized by understanding the global and local environment in which the Quality Processes are embedded. While doing all this, you help maintain a clear picture of the practical functionality of the process, which is why your ability to establish the needed link between compliance and daily use of the processes is so important.

 

You are skilled in communicating across cultures, and has a keen interest in data processing
In this global role, you will be working with numerous colleagues, near and far. You are dependent on their feedback to succeed, which is why your skills as facilitator, communicator and trainer is needed. You are also responsible for the data analysis of the data for KPIs, which you will utilise to improve the process, and determine actions for process optimization. Therefore, your skills as data analyst are also part of the job evaluation.

 

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? 
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
 
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 dklse@coloplast.com. 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.

 

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