IMP QA Manager Clinical Packaging — Roche

Full description

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 IMP Quality Operations Switzerland is responsible for the cGMP-compliant provision of Investigational Medicinal Products (IMPs) for our patients. We are the quality partner for all production units as well as the clinical packaging in the pharmaceutical technical development in Switzerland and carry the overarching quality and compliance responsibility. We are committed to transforming ourselves from the inside into a meaningful organization based on strengthening and role-based work so that every team member can develop optimally. In this role, you act as the deputy of the technically responsible person (FvP) for IMPs in Switzerland and are responsible for the batch release and certification of finished IMP products. As a Quality Partner, you support end-to-end cGMP activities, ensure the right to operate at the Clinical Packaging site in Kaiseraugst and ensure compliance with official and internal quality standards. The position requires a high degree of flexibility, resilience and a deep sense of responsibility.

The possibility

• GMP & operational support: You support quality-relevant packaging processes and work together with the company and other stakeholders on GMP topics.
• Review & Release: You manage the review and release of manufacturing specifications and batch records for semi-finished and finished goods.
• Deviation & Change Management: You actively control deviations and changes to maintain strict quality compliance.
• Project participation: You coordinate local and global improvement projects and accompany corrective and preventive measures (CAPA).
• Process optimization: You engage in improvement initiatives and create, test and implement standard operating procedures (SOPs).
• Cultural contribution: You actively shape a human-centered, self-organized way of working and drive the cultural change towards more agility and innovation.

Who you are

• Education: You have a master’s degree, preferably in life sciences, engineering or a similar field.
• Experience: You bring at least 3 years of experience in the pharmaceutical industry (experience in packaging, master data, quality control or assurance is a plus).
• Technical knowledge: You have in-depth knowledge of cGMP guidelines and quality requirements in clinical development phases.
• Mindset: You are a solution-oriented team player with high self-motivation, innovative spirit and the ability to inspire others.
• Languages: Negotiable communication skills in word and writing in German and English are a must.

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.

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