QA Manager (2 year fixed-term)

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
As a QA Manager (2 year fixed-term), together with your colleagues within QA Sterile Filling, you bear the responsibility that commercial products of the pre-filled syringe line of the Sterile Filling organization meet the specific requirements and that the releases comply both with legal conformity in the customer markets and with the internal Pharma Quality Standard (PQS) requirements. You are the subject matter expert for all quality-relevant questions and the link between bulk manufacturing and aseptic filling, laboratory, as well as other relevant interfaces.

Your area of responsibility includes, among others, the following responsibilities:
Release of the bulk goods manufactured in Kaiseraugst taking into account all GMP and regulatory requirements, including Roche guidelines.
Review and release of manufacturing instructions and Master Batch Records (MBR).
QA responsibility as well as processing and assessment of 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 daily business. Contributing and implementing ideas for improving quality, efficiency of the plants and processes as well as cost reduction. Close cooperation with internal and external interfaces to achieve our ambitious goals for throughput time, quality, engagement and costs.
QA Sterile Filling supports the Sterile Filling organization with telephone on-call duties and is on-site at the respective filling line for qualification activities during Aseptic Process Simulation (Media Fill filling).
Training and taking over new activities in neighboring areas in the sense of polyvalent development, as well as creation and training of SOPs and QA topics.
Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety.

Who are you
You are a positively thinking, integral and self-reflective personality with strong team skills and bring an open and quality-oriented attitude and mindset that is required for successful work in your team and cross-functionally. 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-organized team, with a high degree of personal responsibility in an open and collaborative environment.
Your solution-oriented basic attitude and can-do attitude determines your daily actions.
As a QA Manager, you have a successfully completed degree in the field of pharmacy, natural sciences, engineering or you have a corresponding professional training, combined with several years of professional experience in the GMP area.
Furthermore, you possess the following competencies and skills:
Quick comprehension and great interest in technical processes as well as affinity for dealing with IT systems as well as routine handling of IT systems (e.g. Google applications as well as relevant GMP systems).
Great willingness and curiosity to develop flexibly and to learn cross-functionally in the sense of polyvalence. This includes an interest in grasping, getting to know and improving upstream and downstream process steps. A team-oriented mindset with a view to constant improvement of processes and the ability to provide constant performance at a high level in a constantly changing environment.
Knowledge and committed use regarding process improvements (e.g. Lean Production System) as well as Agile Management are an advantage.
Ability and openness to recognize and live the opportunities and advantages of changes. In this sense, an interest in the areas of coaching and Change Management is an advantage as well as strong communication skills. High teamwork and solution orientation as well as collaborative way of working as well as a pronounced service idea and customer focus.
Very good communication skills in spoken and written German and English.

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.