Head of Quality Systems (m/f/d) 100%

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients. ​We are looking for a passionate Head of Quality Systems to join our growing QA team. You'll be instrumental in shaping our quality framework and ensuring we consistently exceed industry standards.
 
Your responsibilities will include:

• Ensure compliance with regulatory and internal company requirements and international quality standards
• Ensure compliance with the legal requirements for the manufacture of medical devices and reflect in QMS
• Drive the establishment and maintenance of a pharmaceutical quality management system in accordance with EU GMP Guide, CFR and ICH Guidelines
• Support customer audits and health authority inspections, including all related follow-up activities 
• Act as process owner for Quality Work Flows in the QMS
• Compile and report KPIs as part of regular Quality Management Reviews
• Support the implementation of a new QMS from a user perspective
• Support the timely processing of documents, deviations, CAPAs and change requests within the scope of responsibilities.
• Act as system expert for our QMS Trackwise
• Improve internal Quality processes

We are looking for someone with:

• Master’s degree or equivalent in a science discipline
• 10+ years experience in highly regulated pharmaceutical environment
• Experience in personal interaction with customers and Health Authority interactions
• Good communication skills
• QA and manufacturing experience preferred
• Business fluency in English is mandatory
• Fluency in German a strong plus

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees  
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.Click on Apply Now! 

For more information and clarification, please connect Amrith ([email protected]) from our Talent team!

*** No Recruitment Agency, only direct applicants***