P2504 - Clinical Development Quality LeadP2504 - Clinical Development Quality Lead3 weeks ago Be among the first 25 applicantsDebiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique "development only" business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.For our Quality organization based at our Headquarters in Lausanne, we are looking for aClinical Development Quality Lead (CDQL)To ensure excellence in clinical research through proactive quality oversight and GCP compliance. In this key role, you will support stakeholders in vendor qualification, study risk management, team training, and quality coaching while monitoring key risk indicators and trends. Your expertise will help uphold the integrity of clinical trial data, safeguard patient safety, and drive continuous improvement in our clinical development activities. If you are a detail-oriented professional with a passion for quality and collaboration, we invite you to be part of our team.Your responsibilities will be but not limited to:1. GCP Support and OversightProvide GCP support and guidance to clinical development stakeholdersMaintain and manage the CDQL GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly2. Quality Event ManagementSupport stakeholders in managing quality events, including investigations and root cause analysesAssist in the development and implementation of CAPAs to address identified quality issuesVendor Qualification and OversightResponsible for conducting qualification assessment of clinical vendors to ensure compliance with regulatory requirements and internal processesWork closely with stakeholders and vendor QA representatives to ensure effective oversight and continuous monitoringReview and assess study risks in collaboration with stakeholdersFacilitate the identification of study-specific risks and critical data/processesDevelop and generate Key Risk Indicators (KRIs) for studiesMonitor KRIs on a monthly to quarterly basis through analytics and provide insights to stakeholdersPerform trending analyses on KRIs, protocol deviations, and quality events to identify patterns and risksCommunicate potential quality issues identified during KRI reviews and support mitigation planning4. Audit and Inspection ReadinessProvide input to audit management for risk assessments to support the generation of the audit planAssist stakeholders in preparing for audits, including site and vendor audits, regulatory inspections, and internal auditsReview CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements5. Team Training and Compliance OversightPerform follow-up on study document training compliance for the Clinical Trial Team (CTT)Ensure the CTT team remains up to date with protocol training, and study-specific updatesAnalyze quality trends from protocol deviations, KRI reviews, audits, and quality events to recommend continuous improvement initiativesProvide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversightDebiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique "development only" business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.For our Quality organization based at our Headquarters in Lausanne, we are looking for aClinical Development Quality Lead (CDQL)To ensure excellence in clinical research through proactive quality oversight and GCP compliance. In this key role, you will support stakeholders in vendor qualification, study risk management, team training, and quality coaching while monitoring key risk indicators and trends. Your expertise will help uphold the integrity of clinical trial data, safeguard patient safety, and drive continuous improvement in our clinical development activities. If you are a detail-oriented professional with a passion for quality and collaboration, we invite you to be part of our team.Your responsibilities will be but not limited to:1. GCP Support and OversightProvide GCP support and guidance to clinical development stakeholdersMaintain and manage the CDQL GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly2. Quality Event ManagementSupport stakeholders in managing quality events, including investigations and root cause analysesAssist in the development and implementation of CAPAs to address identified quality issuesVendor Qualification and OversightResponsible for conducting qualification assessment of clinical vendors to ensure compliance with regulatory requirements and internal processesWork closely with stakeholders and vendor QA representatives to ensure effective oversight and continuous monitoring3. Risk ManagementReview and assess study risks in collaboration with stakeholdersFacilitate the identification of study-specific risks and critical data/processesDevelop and generate Key Risk Indicators (KRIs) for studiesMonitor KRIs on a monthly to quarterly basis through analytics and provide insights to stakeholdersPerform trending analyses on KRIs, protocol deviations, and quality events to identify patterns and risksCommunicate potential quality issues identified during KRI reviews and support mitigation planning4. Audit and Inspection ReadinessProvide input to audit management for risk assessments to support the generation of the audit planAssist stakeholders in preparing for audits, including site and vendor audits, regulatory inspections, and internal auditsReview CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements5. Team Training and Compliance OversightPerform follow-up on study document training compliance for the Clinical Trial Team (CTT)Ensure the CTT team remains up to date with protocol training, and study-specific updates6. Continuous ImprovementAnalyze quality trends from protocol deviations, KRI reviews, audits, and quality events to recommend continuous improvement initiativesProvide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversightRequirementsUniversity Degree in Sciences or relevant academic background6-8 years' experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & ComplianceExperience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance's including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 complianceStrong experience in the mechanism of multiple QA vendor's oversightExperience in setting and updating SOPsKnowledge of computerized systems validationRigor, flexibility, adaptability and organizationPragmatism focused on efficiency and continuous improvementCapacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities • Fluent in English, French an assetBenefitsInternational, highly dynamic environment with a long term visionCross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industryExposure to a wide variety of areas and functions within clinical development and the pharmaceutical industryParticipation in a company where innovation, people and entrepreneurship are the fundamental keys to successProud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunitiesThe use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesNon-profit Organizations and Primary and Secondary EducationReferrals increase your chances of interviewing at Debiopharm by 2xSign in to set job alerts for “Clinical Lead” roles.Share Your Profile With La Côte International School Aubonne!We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr