Senior Global Process Manager, Document Control & Change Control

Humlebæk, DK

Job Family: Quality Assurance

Country/Region: Denmark

Do you have a passion for driving quality and compliance across global operations?

Coloplast is seeking a Senior Global Process Manager (Global Process Owner) to oversee and optimize two critical quality processes — Document Control and Change Control. This pivotal role will ensure these processes are efficiently managed, aligned with regulatory requirements, and continuously improved to meet the highest quality standards. If you are a strategic thinker with expertise in process governance and quality management, we encourage you to apply!

In this role, you will be responsible for the following:

• Global Process Ownership & Strategy: Lead the end-to-end strategic oversight, implementation, and continuous improvement of Document Control and Change Control processes, ensuring alignment with Coloplast’s quality, regulatory, and business standards.

• Process Governance & Compliance: Ensure the Document Control and Change Control processes adhere to global quality standards, regulatory requirements (e.g., FDA, ISO), and corporate policies.

• Advisory & Business Partnership: Serve as the subject matter expert for both Document Control and Change Control, providing expert guidance to various business areas on 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 Document Control and Change Control, ensuring continuous evaluation and improvement.

• Communication & Presentation: Effectively communicate complex technical concepts related to Document Control and Change Control to both technical and non-technical audiences.

• Continuous Improvement & Standardization: Identify opportunities for process enhancement in Document Control and Change Control to drive efficiency gains, risk reduction, and overall quality improvement.

• Training & Development: Develop and deliver training materials to ensure cross-functional teams are equipped to execute Document Control and Change Control processes effectively.

• Access Control & System Management: Oversee system access for Document Control and Change Control, ensuring that only qualified personnel have access, and that necessary training and documentation are in place.

• System Optimization: Work with IT specialists to ensure that systems supporting Document Control and Change Control processes are optimized and meet evolving business needs.

To be successful in this role, you should have a master’s degree in engineering, pharmacology, or a related field.

You have a minimum of 10 years of experience in the medical device or pharmaceutical industry, with a strong focus on Quality Management Systems (QMS), as well as expertise in Document Control (mandatory) and Change Control processes (preferred).

A deep understanding of regulatory requirements such as FDA, MDD/MDR, and ISO standards is essential.

Additionally, you should be fluent in both written and spoken English and be willing to travel approximately 10-20 days per year.

Your background should also include proven experience in managing stakeholders, optimizing processes, and driving effective cross-functional collaboration.

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 [email protected] 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 Coloplast.com.

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