| || • 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: Bachelor degree or higher in Microbiology, Chemistry or another related science
• Languages: Fluent in English, written and spoken
• Experience: 5 or more years of experience in the pharmaceutical industry, with direct experience with APIs, preferably sterile manufacturing or supplier management. Experience in QC (preferably microbiology), QA Operations, auditing, production and/or other relevant operational areas, should include minimally 3 years in QA, and project management experience. Thorough knowledge of ICH Q7 and other relevant cGMP requirements. Good knowledge of IT systems, strong organizational and communication skills
We are offering a competitive salary in line with the market and based on your qualification, experience and individual competencies. Additionally we are offering an attractive Bonus/Incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The basic salary 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).
Contact: Cornelia Walch, Staffing Manager