Quality Systems Professional

For Sartorius Data Analytics we are currently looking for a Quality Systems Professional to strengthen our team. You will join our Quality team in the Software Product Development, based in Umeå. In this role you will be responsible for securing that our cloud based platform for advanced data analytics for Life science is regulatory compliant. Working in this role you will be improving, harmonizing and maintaining the Quality Management Systems in compliance with current regulatory requirements and standards relevant for our Software.
What you will accomplish together with us:
Responsible for developing and maintaining the Quality Management System and securing its processes & procedures in compliance with regulatory requirements and standards.
Review and perform internal audits on important governance processes to secure its effectiveness & identify gaps for improvements.
Maintain the ISO 9001 certification, including re-certification processes; plan, act & lead.
Vendor qualification, contract negotiation related to QMS and manage customer audits activities.
Drive ISO 27001 matters related to CyberSecurity activities.
Act as expertise around product functional & non-functional requirements with regards to:
ISO 9001
GAMP 5
ALCOA+
Computerized System Validation (CSV)
21 CFR Part 11
GDPR



What will convince us:
Bachelor degree in Life Science, Engineering or related field
Proven experience in implementing and/or maintaining Quality Management Systems is required
Knowledge ISO 9001, ISO 27001, GxP, GAMP 5, 21 CFR Part 11, CSV, ALCOA+ & processes management
Good practice of common IT windows software
You have excellent collaboration and communication skills and good ability to understand stakeholders needs
You are comfortable in taking initiative, work independently and solve problems in a structured way
You have the ability analyze complex information and different types of considerations and exhibit good judgment in statements, actions and decisions



What we offer
Our ambition is to simplify progress in life science research and the biopharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. So that more people can obtain access to better medicine. Nearly 11,000 employees at more than 60 production and sales locations worldwide are committed to this vision. And together, we have grown strongly over the past years. Do you also want to contribute to our vision? Grow with us and benefit from working with a Global Player that has kept its familiar atmosphere:
Opportunity for international career development:
a global network offering seminars and training sessions, expert and manager career paths
Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
Work-life balance: Working from home at many sites
Intelligent working environment: working in smart buildings with the latest technology and equipment
Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025.
We look forward to receiving your application.
www.sartorius.com/career