Manager of quality assurance operations - Home-office based (F/M)

Job

Reporting to the Head of QA/QC CCM, the QA operations manager manages international quality engineers’ team, develops quality skills and pilots the activity. This function pilots the quality assurance among the CCM plants as well as CMOs, ensures support, analyzes data to identify quality improvement actions, pilot harmonization subjects and best practices spread. Build the network needed among the sites.

What you will accomplish together with us

• Pilot quality operation's team, manage capacity and priorities. Provide visibility of future resource needs
• Developp skills, structure the team.
• Is in charge of the team members’ recruitment
• Create a network towards the internal site’s quality teams to create synergies, to share best practices, to build harmonization.
• Is in charge of the quality management of CMOs as such:
  - In collaboration with PSNL team, participate into CMOs selection to make sure they meet the OPS unit specific needs
  - Ensure that quality KPIs are in place with the CMOs and lead the KPIs reviews and related action plans follow-up
  - Interact with CMOs to harmonize practices as much as possible versus internal sites
• Is in charge of Supplier quality activivities for CCM Ops Unit.
• Be the partner of all the Sites (Internal & external Quality managers).
• Support the Sartorius plants about critical investigation/ troubleshooting.
• Drive the consistency & compliance between the sites, be a facilitator about any QA operations topics
• Identify the risks and participate to manage them.
• Analyze data to put in evidence the trends, the risks, the improvements done and to be done.

Profile

• Master's degree in Science, Engineering or biotechnology

• 10+ years of experience in quality assurance with a successful experience as a manager - industries targeted biotech, pharma, API / excipients manufacturing.
• Strong knowledge of GMP, Medical device & industry standards ( 21 CFRs/ ISO13485/ ICH Qs,…)
• You already drove a Quality assurance team.
• You are pragmatic and give sense to your choices. You quickly create good human relationships. You are able to constantly adapt yourself and to shape the future.
• You already drove (or be part of) a quality management system in pharmaceutical industry and/or in an ISO 13485 environment.You want to be part of a dynamic company where quality is a key objective. You want to work for customers manufacturing medicines. You want to be part of a multi-cultural team over the world and be ready to travel in US, Europe and Asia

Company profile

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 15,000 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 even further.