Die 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.
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%.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
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