QA Manager External Supplier Management (f/m)
Area of Responsibility
QA Manager External Supplier Management (f/m), Schaftenau, Tyrol, Austria
25! This is the number of Novartis production sites that our Austrian External Supplier Organization (ESO) Team supports all over the globe. Being part of the ESO team you will be working in a very international team with a lot of global interaction and attractive tasks.
Your responsibilities include, but not limited to:
• Ensuring quality oversight of global drug substance / API suppliers
• Responsibility for monitoring all quality and compliance aspects for purchased API’s supplied into Novartis production sites worldwide
• Managing approval of external suppliers of API and maintain associated quality systems, including the preparation of Quality Agreements and Quality Risk Assessments
• Managing major and critical quality issues, including investigations and appropriate corrective and preventative actions
• Leading supplier qualification process, including related documentation
• Building a solid relationship and providing guidance to our suppliers to achieve a high level of quality standards, including regular supplier visits
What you’ll bring to the role:
• Bachelor or higher in Microbiology, Chemistry or another related science
• Fluent in English, written and spoken (C1)
• 5 or more years of experience in the pharmaceutical industry, with direct experience with APIs, preferably sterile API manufacturing and/or anti-infectives
• Experience in QC / QA Operations, GMP auditing, production and/or other relevant operational areas, should include minimally 3 years in QA
• Thorough knowledge of ICH Q7 and other relevant cGMP requirements for API manufacturers, with first-hand experience with HA inspections
• Any additional language, especially German is a plus
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
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 € 48718,04 per year on a full time basis)
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.