The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. Our technologies help making the development and production of new drugs faster and more efficient, so that more people have access to better medicine. As one of the fastest-growing global life science companies, we are looking for people who share our ambition and want to make a contribution in a vibrant environment.
We are currently seeking a Quality Manager (m|f|d) for Confidence® Validation Services business based at our headquarters in Goettingen, Germany (Sartorius Stedim Biotech). In this position, you will take over the responsibility for the Quality Management System (QMS) at Confidence® Validation Services.
- Providing support to improve and maintain quality system in compliance with current regulatory requirements and internal standards, including anticipation of changes
- Perform document control tasks for ISO 9001 QMS, - reviewing, editing, updating and releasing of documents
- Supporting, coordination and participation in internal and external audits and management review activities
- Implementation, maintenance and training people on complaint and deviation processes, help expedite in escalated cases
- Support by investigation and root cause analysis of lab testing as well as drafting of equipment qualification protocols and reports
- Management and controlling equipment calibration activities
- Network to global and intra site quality units and functions
- Management of quality agreements and support quality questionnaires activities
- Ensuring the expertise in GMP and Quality standards within the organization
What will convince us
- A Bachelor's or a Master's degree preferred in engineering, technical or scientific discipline
- Understanding of the operations of a quality management system and its required documentation.
- Strong experience and knowledge of ISO 9001 and GMP
- Knowledge of laboratory practices (microbiology, chemical engineering)
- Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems.
- Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
- Excellent English and German communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business
- Identification with our core values: Sustainability, Openness, Enjoyment
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. More than 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.