Quality

Water purification

Manager of Product Compliance (m|f|d)

We are currently seeking a Manager of Product Compliance (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 Quality Engineers in our business unit Cell Culture Media (CCM) to ensures the internal and external compliance of our products. Through your team, you are responsible for providing product compliance packages, statements, dossiers,… as well as providing support to all departments involved in supplier management to ensure OPS unit needs are included into suppliers quality management activities.

What you will accomplish together with us

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

  • Be the partner for Customer quality and Regulatory affairs managers to ensure product compliance documentation is accurate and readily available

  • Improve processes related to the generation of the product compliance documentation

  • Provide feedback to the other QA | QC team to facilitate anticipated generation of relevant data

  • Ensure related internal and external requirements | standards are taken into consideration

  • Represent quality management during audits related to product compliance questions

  • Ensure extensive collaboration between your team, site teams and the PSNL team to qualify and maintain outsourced products with harmonized practices across the network

  • Take responsibility for internally outsource products process for the CCM ops units and its continuous improvement

  • Ensure outsource product data base is up to date

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 R12541
  • Employment Mode Full time
  • Position Regular
  • Functional Area Quality
  • Location Goettingen (Germany)