Head of Downstream Processing (DSP) Manufacturing

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.To support a client, a major player in the biotech industry, we are looking for a QA Validation Manager, responsible for the robustness and GMP compliance of critical processes. You'll act as a key link between MSAT, Manufacturing and the client, providing sound, well-documented scientific evidence of process control.Your impact :Drive validation of biotechnological processes in a low-bioburden (cell gene) environmentOversee qualification of related equipment and systems, as well as validation of manual and automated cleaning/sanitization processesEnsure ongoing continuous process verification (CPV) and ownership of validation activitiesServe as the go-to QA contact for product transfer projects and related validation strategyCarry out change control and deviation impact assessments, and support non-conformity investigationsReview and approve GMP documentation: protocols, reports, SOPs, change controls, deviations (process validation, cleaning, CSV)Act as subject matter expert for SOPs covering process and cleaning validationTake part in audits and inspections (European authorities and FDA)Contribute to continuous improvement initiatives and the data integrity programParticipate in risk assessmentsWhat you bring :Bachelor's degree in Science, Biotechnology, or a related field5–7 years of experience in the pharmaceutical industry, within a GMP-regulated environmentStrong knowledge of process validation, cleaning validation, and equipment/system qualificationExperience with change controls, deviation management, and non-conformity investigationsUnderstanding of cell gene manufacturing processes and low-bioburden environmentsFluent English required; German is a plusAbout us :Human-sized company with great colleagues from a large diversity of cultural and professional backgroundsWe do care about our people, communicate openly and value feedbackWork as a team where every member is valued and appreciatedOpportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.Continuous learning and development opportunities via internal or external training and workshopsCompetitive salary package in line with industry practice together with exceptional employment benefitsAt GXP Consulting Switzerland everyone contributes to our joint success and grows individually!If you also share the same passion and values, we will be glad to hear from you! #J-18808-Ljbffr