Senior Global Process Manager, LIMS – work with system management in a global set-up

Job title:

Senior Global Process Manager, LIMS – work with system management in a global set-up

Company:

Coloplast

Job description

In Coloplast, we are embarking on a new important journey implementing a Laboratory Information Management System (LIMS) to provide a structured and automated environment to manage laboratory data. Together with a team from IT and business you will be involved in implementing LIMS, and subsequently assume the role as LIMS Global Process Owner (GPO) and System expert from the business perspective.Join the team
Join the team (Post Market Surveillance, Systems & Processes) as a part of Global Quality, Regulatory Affairs & Sustainability. The team consists of Global Process Owners, Business Application Specialists, and Vigilance Specialists to drive core quality processes and systems and ensure efficient, safe, and reliable products on the market. While each group is specialized within its individual field and works independently, we also enjoy close collaboration and tapping into the synergies that arise when sharing our knowledge.Shared and structured system for laboratory data
Acting as the link between IT and the business, you are responsible for ensuring successful implementation of LIMS globally, ensuring firstly, that the system is functional, validated, and supported, so the organisation can use it, and secondly, also ensure proper activities are initiated to secure further valuable use of LIMS data.Your responsibilities:

• Global Process Ownership & Strategy: Lead the end-to-end strategic oversight, implementation, and continuous improvement of LIMS, ensuring alignment with Coloplast’s quality, regulatory, and business standards. Participate in project scoping and needed input to the selected vendor.
• Process Governance & Compliance: Ensure that LIMS adheres to global quality standards, regulatory requirements (e.g., FDA, ISO), and corporate policies.
• Advisory & Business Partnership: Serve as the subject matter expert for LIMS, providing expert guidance to various business areas on system configuration, specifications, process execution, optimization, and compliance.
• Stakeholder Management & Engagement: Build and maintain strong relationships with global stakeholders, including senior leadership, Local Process Owners, and cross-functional teams.
• Performance Monitoring & Reporting: Define, track, and report on key performance indicators for project and operations, ensuring continuous evaluation and improvement.
• Communication & Presentation: Effectively communicate complex technical concepts to both technical and non-technical audiences.
• Continuous Improvement & System Management: Identify opportunities for process enhancement to drive efficiency gains, risk reduction, and overall quality improvement. Perform or facilitate changes in system configuration – in close collaboration with IT and/or the vendor.
• Training & Development: Develop and deliver training materials to ensure cross-functional teams are equipped to use the system effectively.

Excellent communicator who has experience with system administration
You are an excellent communicator, who has a proven record of acting in the interface between business and IT, and you communicate with ease on multiple levels of an organisation. You can engage in the technical discussions with IT and vendors. You understand user needs and know how to translate IT lingo to make it understandable for our stakeholders in the business.Furthermore, you:

• Have experience with data management systems, preferable LIMS
• Have + 5 years of experience within MedTech or a similar industry
• Have experience with functional support for GxP-critical systems, most likely within the medical device, IVD or pharmaceutical industry
• Have experience with system administration/management
• Are fluent in both spoken and written English

Interested?
If you are a strategic thinker with a passion for process optimization, innovation, and global collaboration, we encourage you to apply. The position will remain open until a suitable candidate is found, so please don’t hesitate to contact Handan Yildiran, Head of Post Market Surveillance, Systems & Processes, at dkhay@coloplast.com for more information.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 .Follow us on . Like us on .58177
#LI-CO

Expected salary

Location

Humlebæk, Hovedstaden

Job date

Wed, 25 Dec 2024 02:28:14 GMT

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