Quality

Water purification

Manager of Project Quality (m|f|d)

We are currently seeking a Manager of Project Quality (m|f|d) for our Quality Assurance & Control CCM business based at our headquarters in Goettingen, Germany (Sartorius Stedim Biotech GmbH). In this position, you will lead a global team of Project Quality Engineers in our business unit Cell Culture Media (CCM) to ensures that products and process meet quality, compliance and customer requirements in defined projects. The overall goal is to ensure functional, safety and regulatory compliance of products and processes for a robust industrialization and launch of new products.

What you will accomplish together with us

  • Lead the Project Quality Engineers team, manage capacity and priorities. Provide visibility of future resource needs and develop skills and structure within the team

  • Be the partner for CI&T, product development, marketing and other quality teams managers to promote quality mind set and remove road blocks from projects

  • Communicate about projects with customers, CMOs, with local sites and other Sartorius Operational Units as well as with upper management

  • Collaborate closely with Regulatory Affairs Managers to ensure regulatory needs are embedded into projects

  • Ensure internal and external requirements | standards are taken into consideration during product and process development

  • Represent quality management during audits related to projects

  • Monitor the progress and effectiveness of the project quality management system and improve development process quality accordingly

  • Support risk management activities

  • Act as project quality engineer in complex and business critical projects

What will convince us

  • Master's degree in Science, Engineering or biotechnology

  • Several years of relevant experience in Project Quality with a successful experience as a manager - industries targeted biotech, pharma, API | Excipients manufacturing or culture media.

  • Strong knowledge of GMP, Medical device & industry standards ( 21 CFRs |  ISO13485 | ICH Qs,…)

  • Good planning and project management skills

  • Proven understanding of data analysis and statistical methods

  • Experience in an international working environment and in leading a global team

  • Fluent in English and willingness to travel globally (approx. 30%)

  • Identification with our core values: Sustainability, Openness, Enjoyment

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 for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.

Further insights into our world of work can be found here.

Laboratory Weighing Services
  • Reference Number R12522
  • Employment Mode Full time
  • Position Regular
  • Functional Area Quality
  • Location Goettingen (Germany)