P2313 - Clinical Development Quality Lead Jobs in Lausanne, Switzerland


Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique development only business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.Here: https://apply.workable.com/debiopharm-group-sa/For our Quality Management Ramp;D organization based at our Headquarters in Lausanne, we are looking for a Clinical Development Quality LeadMission:The Clinical Development Quality Lead contributes to the implementation of the Quality Strategy in order to support Debiopharm International’s day-to-day clinical trial activities from a cross-functional end-to-end perspective by applying the pro-active quality principles and providing continuous support and input during the Clinical Development Activities.Your responsibilities will be but not limited to:Develop a risk-based compound-specific compliance program contributing to document / data accuracy, ultimately resulting in dossier acceptability by respective out-licensing partners (emphasis on eCTD Module 5)Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirementsCollaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up amp; oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processesProvide compliance support and contribute to in process / ongoing oversight through evaluation amp; follow-up on reported quality events potentially jeopardizing the validity of the clinical studyCollaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency e.g. IB versus Clinical Trial Protocol versus Master Informed Consent Form, Applying the risk-based approach, identify the need to amp; conduct co-auditing activities / quality visits with DPI and / or CRO representativesProvide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementationCreate KQI to identify areas for improvement based on risk-based compliance activities and audit observationsLead / contribute to compound-specific Regulatory Authority Inspections / Due Diligence ActivitiesBuild collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organizationProvide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-upProvide support to the development / maintenance of QM and ClinDev related Procedural Documents

Original jobs : https://ch.mustakbil.com/jobs/job/874247