GMP Compliance Specialist

For our customer a big pharmaceutical company in Basel we are looking for a highly qualified GMP Compliance Specialist (m/f/d).

Background: 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.

Ihre Aufgaben

• 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

Ihr Profil

You have a Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry. 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. You are fluent in German and have good verbal and written communication skills in English. You have a detail-oriented and analytical mindset with the ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements. You demonstrate excellent communication skills and the ability to collaborate efficiently with interdisciplinary teams in a dynamic environment. You appreciate being empowered to make decisions in your own field of expertise and actively seek feedback from others.,

• 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.

  Nice to have:

• 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.