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As our team at our HQ in Rheinfelden is growing, we are looking for a

CSV QA Manager

Who we are

Tillotts Pharma ( is a fast-growing international specialty Pharma company located outside of Basel employing over 300 employees in Switzerland and abroad. We are dedicated to the development, in/out-licensing, acquisitions and marketing of innovative pharmaceutical products in the field of gastroenterology and specialty products. We successfully market our own as well as in-licensed and acquired products in over 65 countries through our affiliates as well as a network of carefully chosen licensing- and marketing partners. We are engaged in close collaborations with pharmaceutical research centers and universities. Tillotts group is reporting in IFRS and consolidating different affiliates in Europe.

Who we are

Are you looking for an exciting role that offers you to contribute to the growth of an international fast-growing company? Then don’t miss this chance to join us!

We offer a dynamic environment, in which you will be working with teams and stakeholders across all geographies and levels. As a member of our QA Team, you will put things into action and further strengthen our Tillotts’ culture – the engine of our success – by applying your knowledge and expertise.

Your key responsibilities

  • ERP Key User and Core Team Member (incl. Master Data Management) for QA Department Rheinfelden
  • eQMS Key User and Core Team Member
  • eQMS Control Business Administrator
  • Ensurance of Software and IT compliance: Excel spreadsheet validation, computerized system validation, supplier (re)qualification for computerized systems and services
  • Responsible for QA related tasks for IT Changes
  • Responsible for QA related tasks for Serialisation
  • Review and approval of computerized system validation in general
  • Represent QA in CSV-related projects
  • Supervision of QA relevant issues/processes and support with focus in GxP-related computerized systems, IT, ERP, Serialisation, and other computerized systems
  • Manage and maintain the revisions/compilations of quality documents (incl. SOP, work instructions, policies, etc.)
  • Training of departments in GMP topics
  • Keep track on new regulatory guidelines and implement them together with the QA Team at Tillotts
  • Completion of internal and external audits
  • Responsible for QA related tasks for Data Integrity

Who you are

  • Minimum bachelor’s degree in a life science-related discipline
  • At least 2 years’ experience in Quality Assurance or GMP Manufacturing
  • At least 2 years’ experience in Computerized Systems Validation (CSV)
  • Excellent knowledge and understanding of regulatory requirements such as GMP (including 21 CFR Part 11 and EU GMP Guide Annex 11) and GAMP5 guidelines.
  • Fluency in English and German (in written and spoken)
  • Motivated team player with a problem-solving mindset
  • Agile and dynamic drive to navigate in a fast-paced working environment
  • Pro-active work style with good communication skills
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions
  • Ability to work under pressure and prioritize tasks
  • Willingness to travel (5%)

What we offer

  • A great opportunity to work in a diverse environment where you can develop your existing competences and acquire new skills.
  • A familial working environment where you can directly shape and affect our business. You will be in the front line working with various departments with high visibility to senior management.
  • A highly flexible workplace where we respect Work-Life balance and where open communication and great team spirit is highly valued.
Please note that we only accept direct applications (no recruitment companies)
- Human Resources, Tillotts Pharma AG

Yolanda Perez is looking forward to receiving your complete application