QA Manager in the area of Sterile Filling (2 years limited)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The position As QA Manager*in, you, together with your colleagues, within the QA Sterile Filling take responsibility for ensuring that commercial products of the Fertigspritzen-Linie of the Sterile Filling Organisation meet the specific requirements and the releases are in line with both legal compliance in customer markets and internal Pharma Quality Standard (PQS) requirements. You are the expert for all quality-relevant questions and the link between bulk production and aseptic filling, laboratory, and other relevant interfaces. Your area of responsibility includes, among other things, the following responsibilities: Release of bulk goods produced in Kaiseraugst, taking into account all GMP and regulatory requirements, including Roche guidelines. Checking and releasing manufacturing instructions and Master Batch Records (MBR) QA responsibility as well as processing and evaluating Deviations, CAPAs and Changes as well as other GMP documents. Together with the team, driving forward Lean Production System methods and tools and living them in everyday life. Bringing in and implementing ideas for improving quality, efficiency of facilities and processes as well as cost reduction. Close cooperation with internal and external interfaces to achieve our ambitious goals for lead time, quality, engagement and costs. Training and taking over new tasks in adjacent areas in the sense of polyvalent further development, as well as creating and training SOPs and QA topics Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety. Who you are You are a positively thinking, integral and self-reflective personality with strong team skills and bring an open and quality-oriented attitude and way of thinking that is required for successful work in your team and across departments. You trust yourself and others, take responsibility and live an open Speak-Up and error culture. Furthermore, you have the willingness to work in a self-organised team with a high degree of personal responsibility in an open and collaborative environment. Your solution-oriented basic attitude and Can-Do attitude determine your daily actions. As QA Manager*in, you have a successfully completed degree in the field of pharmacy, natural sciences, engineering sciences or have equivalent professional training, combined with several years of professional experience in the GMP area. In addition, you have the following skills and abilities: Quick comprehension and great interest in technical processes as well as affinity in handling IT systems and routine handling of IT systems (e.g. Google applications and relevant GMP systems) Great willingness and curiosity to develop flexibly and learn across departments in the sense of polyvalence. This includes an interest in grasping, getting to know and improving preceding and subsequent process steps. A team-oriented way of thinking with a view to constantly improving processes and the ability to deliver consistent performance at a high level in a constantly changing environment. Knowledge and convinced use of process improvements (e.g. Lean Production System) as well as Agile Management are advantageous. Ability and openness to recognise and live the opportunities and advantages of changes. In this sense, an interest in the areas of coaching and change management is advantageous, as well as a pronounced communication ability. High team ability and solution orientation as well as collaborative way of working and pronounced service-oriented thinking and customer focus Very good communication skills in word and writing in German and English. Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Who we are A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.