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Quality Management System Manager

2 maanden geleden

Utrecht, Utrecht, Nederland SkyCell AG Voltijd
About the Role

We are seeking an experienced Quality Management System Manager to join our team at SkyCell AG. 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 SkyCell AG

We are a diverse and quality-conscious company, which has set itself the goal of transporting temperature-sensitive medicines in a more reliable and sustainable way. We help save lives and preserve the environment.

We are looking for people who challenge the status quo and thrive on making a difference to people and the world around us. That's where our Improvement and Quality team play a pivotal role and you could be a part of it.

We are Innovative Award Winners: We're driven by our core values and guided by our collaborations, purpose, and employees. Our commitment to changing the face of medical supply chains, making them safer, more secure, and more sustainable resonates strongly with every one of our employees; we're therefore incredibly proud to have been certified as a Great Place to Work alongside being awarded a sustainability rating of Platinum by EcoVadis.