Quality Management System Manager

2 dagen geleden

Utrecht, Utrecht, Nederland SkyCell AG Voltijd
About SkyCell AG

SkyCell AG is a leading provider of innovative logistics solutions for the pharmaceutical industry. With a strong commitment to quality and sustainability, we strive to make a positive impact on the environment and society.

Job Description

We are seeking an experienced Quality Integrated Management System Manager to join our team. As a key member of our Improvement and Quality team, you will play a crucial role in ensuring the highest standards of product and service quality.

Key Responsibilities
  • Lead software validation processes and documentation management within various software development methodologies (mainly Agile)
  • Ensure the development and delivery of our supply chain platform and SkyCell's IoT infrastructure is done in accordance with GxP requirements (in particular GAMP-5), including 21 CFR Part 11 and EU GMP Annex 11
  • Participate as QA Representative in the software development process, evaluating the GxP impact of software enhancements and fostering a culture of quality
  • Lead certification process with third party auditors for GAMP-5, 21 CFR Part 11 and EU GMP Annex 11 (and other industry-relevant certifications)
  • Support the embedded IoT team in obtaining approvals and certifications relevant for airline and pharma industries
Requirements
  • Demonstrated experience in building systems compliant with ISO27001 standards
  • Extensive knowledge of ISO27001 and related technical standards, including FDA 21CFR Part 11 and EU GMP Annex 11
  • Exceptional auditing skills and several years of experience in both internal and external audits
  • Proficiency in software development methodologies such as Agile Scrum, with the ability to incorporate quality and compliance practices within an Agile framework
  • Experience in corporate, process and project risk management (e.g. PMI-RMP Risk and/or several years' experience)
  • Project and change management experience
  • A strong continuous improvement mindset and experience in process improvements
  • Outstanding documentation, communication, leadership, and problem-solving skills
  • Excellent digital skills, ability to easily learn software tools and apply them effectively
  • Familiarity with Quality Management System based on ISO 9001:2015 is advantageous
  • Willingness to undertake occasional business travel when required
  • Excellent English skills, both spoken and written
What We Offer
  • Flexible working hours for work/life balance
  • Interdisciplinary and varied projects
  • Diverse and global work culture/environment
  • Possibility to work for an environmentally conscious company
  • Unique opportunity to actively shape processes
About the Role

This is an exciting opportunity to join a dynamic and innovative company that is shaping the future of logistics. As a Quality Integrated Management System Manager, you will have the chance to make a real impact on our business and contribute to our mission of making a positive difference in the world.

We are an equal opportunities employer and welcome applications from diverse candidates. Please note that we only consider direct applications.

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