Are you at your best when you get to work at the interface between Quality, IT and business?
Join Coloplast and grab this opportunity to take on a role where you act as the link between IT and the business and be responsible for translating business needs into tangible solutions in the quality management systems.
Join the team
Coloplast is looking for a Senior Business Application Specialist, to join the team that consists of process – and system specialists. While everyone is specialized within their field and work independently, we enjoy close collaboration and tapping into the synergies that arise when sharing our knowledge.
Help ensure continuously validated systems
As a Senior Business Application Specialist, you will improve and optimize the business processes, especially in the quality systems domain, like Veeva QualityDocs and Veeva QMS. Furthermore, to manage requests, questions, and other support, which requires a good combination of IT system knowledge and business process understanding/experience. Furthermore, we expect you to communicate with stakeholders in both headquarters and globally at our manufacturing sites and subsidiaries. Thus, you can engage in the technical discussions with IT and vendors, you understand user needs and you know how to translate IT lingo and make it understandable for other stakeholders in the business.
Your main tasks and responsibilities will be to:
- Act as Business Owner for Veeva Quality Management System and as second level functional support for Veeva
- Support and engage in maintenance of system-related documentation
- Take part in and facilitate the implementation of system changes (incl. configurations, change management, trouble shooting, and required validation activities for new features and functions) - in close collaboration with IT, system vendors, process owners
- Collaborate with IT and business stakeholders to align Veeva system with global quality strategies
- Participate in Innovation days with the vendor to discuss and align new features, and provide input that meets the organizational needs
- Translate business requirements to technical specifications
- Engage and lead training related activities to further support the training and learning journey throughout the organization
- Develop training material (including e-learning) and carry out training sessions
- Participate in future projects as Functional Lead, Subject Matter Expert or as Project Manager (demonstrate the ability to apply project management methodologies and contribute to project teams)
- Continue to improve procedures, work instructions, templates, and other tools to optimize the systems and related processes for operating and maintaining the systems
- Work with multi-disciplinary teams to ensure project delivery, meeting stakeholders’ requirements
- Prepare and contribute to audits (internal and external) and inspections of the systems
Requirements
- Relevant academic degree e.g. in Life Science, IT, Engineering or similar area
- Minimum 5 years of work experience from medical device or pharmaceutical industry, and minimum 3 years’ experience from a similar role
- Have experience with GxP systems, GAMP, IT validation, test management, and preferably within the medical device or pharmaceutical industry
- Preferred practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification
- Preferred experience in IT GxP projects, either as project SME, functional – or project lead
- It is an advantage if you have collaborated with stakeholders, such as development and optimization of quality systems and processes
- It is an advantage if you have experience with IT test tools (Jira, etc.)
Furthermore,
- You are fluent in English, both spoken and written
- You have the the ability to work independently as well as in teams (with diverse backgrounds)
- Service minded and meeting challenges with a smile and a positive mindset
- Pragmatic attitude, able to balance, and see other people´s perspective
- Structured and systematic, and can adapt the level of right detail to the context
Our culture is one of trust, fun and creativity, with a strong focus on quality and compliance. We are part of the Global Quality, Regulatory Affairs & Sustainability organization and work out of Humlebæk with the opportunity to work from home on a schedule agreed with the direct manager.
Interested?
If you would like to know more about the position, please contact Head of PMS, System & Processes, Handan Yildiran, dkhay@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 is 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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