Transfer/Launch Manager ASAT E2E Bio

Descrizione del lavoro:

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

Quality Control (QC) Basel/Kaiseraugst consists of approximately 350 employees, organized into 7 departments with subordinate structures. It serves as a central key point for producing high-quality medicines. BS/KAU is responsible for the analytical quality testing of an extensive product portfolio, ranging from drug substances and drug products to medical devices, bulk, finished goods, direct materials, and packaging materials.
As a specialized section within this structure, Analytical Science and Technology (ASAT) is responsible for the strategic implementation of modern testing methods and innovative technologies at the Quality Control (QC) Basel/Kaiseraugst site. We act as a central hub of expertise, not only establishing methods locally but also actively transferring them to other sites. By managing the entire product lifecycle on an end-to-end (E2E) basis, we provide global standardization and technical steering. This ensures our 'Right to Operate', consistent compliance, and the highest quality standards throughout the entire Roche network.
As a specialized section within this structure, Analytical Science and Technology (ASAT) is responsible for the strategic implementation of modern testing methods and innovative technologies at the Quality Control (QC) Basel/Kaiseraugst site. We act as a central hub of expertise, not only establishing methods locally but also actively transferring them to other sites. By managing the entire product lifecycle on an end-to-end (E2E) basis, we provide global standardization and technical steering. This ensures our 'Right to Operate', consistent compliance, and the highest quality standards throughout the entire Roche network.

The Opportunity

As you step into this role, you will lead critical initiatives that harmonize our global analytical operations and drive technical excellence.
* Lead and coordinate projects in close collaboration with cross-functional interfaces like Pharmaceutical Development, Manufacturing Operations, and Commercial QC.
* Drive network agility by actively participating in global project teams to promote standardization across the Roche network.
* Spearhead technology implementation, serving as the primary point of contact for internal and external partners regarding new analytical technologies.
* Provide strategic support for ASAT objectives while managing specific technical assignments and ensuring seamless method transfers.
* Author GMP documentation, including transfer/validation plans, reports, risk assessments, and SOPs, while managing Change Controls and Deviations as an SME.
* Support audit readiness by preparing for and executing health authority inspections to maintain the site's Right to Operate.
* Manage lifecycle robustly, ensuring consistent analytical standards and technical steering throughout the product lifecycle.

Who You Are

You are a positive, self-reflective professional who thrives in a collaborative environment and values an open speak-up culture.
* Educated and experienced: You hold a degree in Life Sciences (Chemistry, Pharmacy, Biotech) or a technical field, paired with several years of experience in a quality/GMP environment.
* Technically proficient: You possess a fundamental understanding of safety and quality systems, backed by a strong analytical background for solving complex issues.
* Proactive and organized: You demonstrate a high degree of self-initiative, quick comprehension, and a solution-oriented, self-reliant way of working.
* Collaborative and agile: You have distinct interdisciplinary understanding and the ability to operate flexibly within a dynamic, global network.
* Linguistically skilled: You possess business-level proficiency in both German and English (written and spoken) and are looking for a workload of 80-100%.

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