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.
Are you passionate about Quality and looking for an impactful leadership role? As a member of the Kaiseraugst Quality Leadership Team, you will play a pivotal role in shaping and advancing our quality efforts. You will be a driving force for continuous improvement and compliance, fostering an open, learning-oriented culture where excellence is the standard.
You will define the overall Quality strategy and set long-term goals. You will act as the key business partner for the Kaiseraugst site and the entire network.
You will ensure a constant state of inspection readiness by identifying, escalating, and mitigating compliance risks. You will lead regulatory inspections, audits, and the internal self-inspection program.
You will oversee and enhance Quality Management Systems (QMS), including the management of the Document Center, change management, risk assessments, and the timely preparation of Annual Product Quality Reviews (APQRs).
You will take strategic oversight of complaint management and lead the coordination of major issues at the site, acting as the central interface with global issue management.
You are responsible for ensuring full compliance with all requirements from Health Authorities and Roche policies, and will manage the Site Master File, as well as Quality Agreements and Service Level Agreements.
You will analyze and improve data/KPI set up to drive site performance and prepare local MRoQ as well prepare global MRoQs from site perspective
You will embody the VACC model, creating an environment of trust and open communication, where learning from failure is encouraged and success is celebrated.
You will promote a positive safety culture, manage your departmental budget, and champion a continuous improvement mindset.
You are a positive and self-reflective individual with a strong sense of integrity and a highly collaborative spirit. You approach challenges with a solution-oriented, can-do mindset and a keen service focus. You have a quick grasp of new concepts and a genuine curiosity for technical processes. Trusting yourself and others, you take ownership and champion an open "speak-up" culture where learning from failure is encouraged. You are committed to your own professional growth and have a desire for polyvalent development, actively seeking to understand upstream and downstream processes.
Furthermore, you bring the below experience and qualifications:
At least 10 years of professional experience in the pharmaceutical or a related industry, with a minimum of 4 years in a quality or compliance function.
Demonstrated experience in leading and developing teams, or equivalent lateral leadership experience.
A graduate or higher-level degree in life sciences, chemistry, natural sciences, or engineering.
Expert knowledge of Quality System principles, audit and inspection management, and aseptic filling. Knowledge of Quality Risk Management and medical devices is a plus.
Excellent communication skills in both German and English, a routine proficiency with IT systems, and a proven application of Lean and agile methodologies.
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
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.