QA Manager Compliance (fixed-term for 1.5 years)

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 PositionAt Roche, quality is at the center, as it represents the right of every patient and the duty of every employee. It is the key to success, as our products have a direct impact on people's lives. Become part of the team at Basel Drug Substance and contribute to ensuring and further developing high quality standards, especially in the area of compliance.As Quality Assurance Manager, you are responsible for the compliance and continuous improvement of the pharmaceutical quality system of Roche Pharma as well as for the fulfillment of regulatory requirements.The OpportunityAs QA Manager Compliance, you are a central link in our quality team with a strong focus on ensuring compliance. Your main tasks include:Inspection Management: You lead and accompany audits as well as inspections by health authorities and act as an important SPOC for the Inspection Management Team.Technical Writing: You create, review and approve complex technical documents (e.g. SOPs and reports) to transparently consolidate global compliance standards at the site.Regulatory Implementation: You precisely interpret local as well as international GMP regulations and anchor them securely in daily operations.Collaboration and Coaching: You serve as a central compliance coach for various units, participate in huddles and maintain constructive cooperation with internal and external stakeholders.Process Optimization & AI: You maintain the Inspection Readiness Dashboard, proactively question risks and specifically use applications of Artificial Intelligence to rethink processes and drive innovation.International Networking: You act as a link to other sites to exchange findings as well as best practices and to support a consistent global compliance strategy.Change Management: You actively support the processing of reportable changes (e.g. Swissmedic Notifications) to ensure continuous regulatory compliance.Who you areTo be successful in this role, you bring the following profile:Education & Experience: You have a completed degree in natural sciences as well as at least 5 years of relevant professional experience in the pharmaceutical sector with a strong focus on quality assurance.Expertise & Analytics: You bring comprehensive knowledge of current local and international GMP standards and possess strong analytical skills to interpret complex cGMP requirements and assess compliance risks.Communication & Leadership: You have the ability to work constructively with interdisciplinary teams and manage to inspire interface partners at all levels in a goal-oriented manner, even without direct personnel responsibility.Documentation Expertise: You demonstrate pronounced expertise in technical writing and can translate complex technical facts as well as regulatory requirements into understandable, structured and audit-proof documents.Technology & Language: You speak and write fluently in German as well as English, are proficient in using IT applications (e.g. Google Drive, Monday) and have a high affinity for breaking open traditional processes through the use of AI.Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!   Who we areA 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.