QA Manager (m/f)


      Schaftenau - vor 4 Wochen

      Come join us and become a part of our world. Together we can discover new ways to improve and extend people's lives. As part of the global Novartis Group our sites in Kundl and Schaftenau are specialized in development and production of antibiotics and biologics.

      QA Manager (m/f)

      External Supply Operations, Schaftenau

      Area of Responsibility

      • Responsible for monitoring all quality and compliance aspects, having quality oversight for purchased API's and strategically important regulatory starting materials and chemical intermediates supplied into Novartis sites worldwide
      • Manage and maintain the approval, qualification and certification status for all external Suppliers and all associated quality systems
      • Manage major and critical quality issues according to the Quality Agreement and the Novartis Quality Manual
      • Ensure investigations are correctly executed and all appropriate Corrective and Preventative actions are put in place
      • Lead External Suppliers Qualification process, maintain and update documents related to the supplier qualification and monitoring
      • Provide direction and support to third parties and ensure their high level of competence and that the Chemicals produced meet the Novartis quality, efficacy and safety requirements
      • Responsible for preparing Quality Agreements and Quality Risk assessments for all External Suppliers
      • Support escalation process by assessing quality and compliance risks arising from observations noted in inspections/audits of suppliers.
      • Maintain regular interactions with supplier, including supplier visits


      Education: Academic degree in Microbiology, Chemistry or another related science
      Languages: Fluent in English, written and spoken. German is desirable.
      Experience: 5 or more years of experience in the pharmaceutical industry, with direct experience with APIs, preferably sterile manufacturing or supplier management. Experience in QA Operations, auditing, production and/or other relevant operational areas. Thorough knowledge of relevant cGMP requirements. Good knowledge of IT systems, strong organizational and communication skills

      Please apply online under the following link Online Application (Job ID 242804BR)
      Contact: Iskra Kostadinova, Talent Acquistion and Staffing

      We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 52.048,50 per year).

      Sandoz GmbH
      Biochemiestrasse 10
      6250 Kundl, Austria
      Tel. 05338/200-0