IT Quality Assurance Manager

 

Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Coloplast Business Centre we are responsible for global financial operations, orders administration, HR, IT, Legal support, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition, you can be a part of this exciting challenge. Curiosity works here!

About the department

Portfolio, Transition, and Release Services Department

The Portfolio, Transition, and Release Services department is an integral part of the Digital, Data & IT (DD&IT) organization. Our mission is to support our colleagues across DD&IT by ensuring adherence to procedures, empowering quality, and maintaining compliance. We are dedicated to fostering innovation and driving continuous improvement in all our endeavors.

We collaborate closely with all levels of the business, whether the task at hand involves large-scale programs, projects, continuous improvements, or change requests. Our multidisciplinary team of seven professionals, based in Poland (Szczecin & Warsaw) and Denmark (Copenhagen), brings a diverse range of skills and perspectives to the table.

Leveraging tools like MS Teams for seamless collaboration, we also meet in person quarterly to strengthen our team bonds through workshops and social activities. Together, we strive to grow individually and collectively, upholding the highest professional standards and continuously seeking innovative solutions to enhance our work.

About the job

Are you structured, detail-oriented, and passionate about working with documentation and processes? Do you enjoy collaborating with colleagues from various parts of IT and business organizations to ensure high-quality deliverables? If so, we have an exciting opportunity for you!

We are seeking a dedicated IT Quality Assurance Manager to establish and expand the DD&IT QA management area. In this role, you will be responsible for overseeing our IT Software Validation procedures and collaborating with the Coloplast Quality organization to continuously enhance our IT Quality Assurance framework.

Your daily responsibilities will include working closely with the IT Service Transition team and the Project and Test Management department. You will play a key role in driving innovation and continuous improvement within our IT Quality Assurance processes.

 Your responsibilities

• Oversee IT Software Validation Procedures: Ensure all software validation processes are conducted in compliance with industry standards and regulatory requirements.
• Collaborate with Quality Organizations: Work closely with the Coloplast Quality organization to enhance and maintain the IT Quality Assurance framework. Participate in internal and external quality related audits
• Support IT Service Transition: Partner with the IT Service Transition team to ensure smooth transitions and high-quality deliverables.
• Engage in Project and Test Management: Collaborate with the Project and Test Management department to integrate quality assurance practices into project lifecycles.
• QA Review and Approval: Perform quality assurance reviews and approvals for IT changes related to various IT systems (GxP), including validation plans and validation reports.

• Maintain Documentation: Develop and maintain comprehensive documentation for all quality assurance processes and procedures.
• Ensure Regulatory Compliance: Stay updated on relevant regulations and ensure all IT quality assurance activities comply with these standards.
• Provide Training and Support: Offer guidance and training to team members and stakeholders on quality assurance, best practices and procedures.
• Collaborate with SaMD QA Specialist: Work closely with the SaMD QA Specialist to ensure balanced workloads and mutual coverage.
• Compliance Overview: Serve as the single point of contact for DD&IT management, Global Quality, and projects, and participate in projects as the QA responsible.
• Drive Continuous Improvement: Identify opportunities for process improvements and implement innovative solutions to enhance IT Quality Assurance.

Requirements 

Experience and Industry Knowledge

• Several years of experience from a global organization in quality assurance, particularly in the medical device or healthcare software industry
• Understanding of the impact of GxP critical processes
• Knowledge of regulatory requirements for medical devices and/or computerized systems validation (e.g., ISO 13485:2016, ISO 27001, FDA 21 CFR Part 11, EU Annex 11)

Technical Skills and Proficiency

• Proficiency in IT software validation and external quality standards
• Familiarity with QMS systems, especially Veeva
• Good grasp of frameworks such as ITIL, GAMP, SAFe

Legal and Compliance Knowledge

• Basic understanding of personal data handling legislation

Communication and Interpersonal Skills

• Excellent English verbal and written communication skills to interact with team members, regulatory bodies, and other stakeholders

Availability and Flexibility

• Available for travelling up to 15 days per year

Competences

• Relevant academic background, such as an MSc in Computer Science, Engineering or a similar field.
• 2-4 years of experience working with compliance in IT systems within regulated industries (Medical Device or Pharma).
• Aptitude for working with IT applications and a strong business interest
• Proven track record of providing compliance and QA support for IT projects and changes.
• Outgoing personality with the ability to work both in teams and independently. You excel in delivering results through effective collaboration and dialogue. You are structured, with strong skills in prioritizing, planning, and completing tasks.

We offer

•    No probation period – long-term contract from the start 

•    Hybrid work possibilities
•    Office hours Mon - Fri
•    International work environment with Scandinavian culture
•    Opportunity to use and develop foreign languages in daily work
•    Fantastic work atmosphere full of respect and partnership 
•    Internal trainings available in our CPBC Academy

 
That's not all! We have even more for you:
•    Modern workplace
•    No dress code zone
•    Great company events
•    Sports card
•    Private medical care
•    Transportation co-funding
•    Restaurant card
•    Holiday bonus and occasional cards
•    Delicious coffee and fresh fruits

 
Recruitment details

Please apply online with your CV in English. 
We will review all applications continuously and invite selected candidates further to the recruitment process. We will close the offer down once we find the best match to the role. 

#LI-Hybrid

Please apply by sending your application in English.

If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl  
 
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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