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For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated GMP Compliance Specialist for a long temporary contract.

In Roche's Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world's toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicine. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

This position is located in Preclinical Chemistry, Manufacturing, and Controls (pCMC), a department within the Small Molecule Research organization in pRED Therapeutic Modalities (TMo), where we pave, in a diverse, ambitious and innovative environment, the path to bring drug candidates from early research into development. We collaborate actively with our discovery and development partners functions providing cutting-edge technologies and scientific excellence to transform molecules into future medicines. We are CMC experts and build our strength on a broad diversity of technical expertise in chemistry, formulation design, material science and analytical chemistry, delivering and innovating in the space of small molecules, peptides and nucleic acid-based medicines.

• Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
• Being an expert and first level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM,)
• Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
• Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
• Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
• Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries

• Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
• Operational experience in a GMP environment within the pharmaceutical industry
• MS office / standard Google applications
• Fluent in German, good verbal and written communication skills in English
• Soft skills: detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic environment

• Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus.

Are you interested? Do not hesitate and submit your complete application documents online today.

We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

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