T2609 Clinical Development Quality Manager (contractor until end of May 2027)

ph3Mission /h3 pThe Clinical Development Quality Manager (CDQM) is responsible for ensuring quality oversight across clinical development activities and supporting the maintenance of GCP compliance. This role supports stakeholders in vendor qualification, study risk management, quality oversight, team training compliance, and coaching as needed. Responsibilities include monitoring Key Quality Indicators (KQIs), analyzing trends in quality events, ensuring protocol adherence and providing support for quality events, audits, and corrective and preventive actions (CAPAs). The CDQM measures proactive identification and mitigation of risks to maintain the integrity of clinical trial data and protect patient safety. /p h3Main Responsibilities /h3 ul libGCP Support and Oversight: /b Provide GCP support and guidance to clinical development stakeholders. Maintain and manage the CDQM GCP query log, ensuring all GCP-related queries are logged, tracked, and resolved promptly. /li libVendor Qualification and Oversight: /b Responsible for conducting qualification assessments of clinical service providers to ensure compliance with regulatory requirements and internal processes. Work closely with internal stakeholders and service providers to ensure effective oversight and continuous monitoring. /li libRisk Management: /b Review and assess study risks in collaboration with stakeholders. Facilitate the identification of study‑specific risks and critical quality factors. Monitor KQIs monthly to quarterly, provide insights to stakeholders, perform trending analyses on KQIs and quality events to identify patterns and risks. Communicate potential quality issues identified during KQI reviews and support mitigation planning. /li libAudit and Inspection Readiness: /b Provide input to audit management for risk assessments to support the generation of the audit plan. Support stakeholders in preparing for audits, including site and service provider audits, regulatory inspections, and internal audits. Review CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements. /li libQuality Events and Deviations Management: /b Support stakeholders in managing quality events and deviations, including investigations and root cause analyses. Assist in the development and implementation of CAPAs to address identified quality events and deviations. /li libTeam Training and Compliance Oversight: /b Perform follow‑up study document training compliance for the Clinical Trial Team (CTT). Ensure the CTT team remains up to date with protocol training and study‑specific updates. /li libContinuous Improvement: /b Analyze quality trends from KQI reviews, audits, and quality events to recommend continuous improvement initiatives. Provide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversight. /li /ul h3Profile /h3 ul liUniversity degree in science or relevant academic background. /li li4‑5 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within a Clinical Quality Management System Compliance. /li liExperience in managing and conducting GCP audits (internal processes, service providers, TMF, investigational sites, and CSR). /li liExcellent knowledge of GCP, current regulations, and strong working knowledge of GCP, CFR Title 21, and regulatory guidance including ICH E6‑R3 implementation, multidisciplinary guidance documents, and 21 CFR Part 11 compliance. /li liStrong experience in the mechanism of multiple QA service provider oversight. /li liExperience in setting and updating SOPs. /li liKnowledge of computerized systems validation. /li liRigor, adaptability, proactivity, and organization. /li liPragmatism focused on efficiency and continuous improvement. /li liCapacity to think strategically and keep an overall view while bringing efficiency to daily detailed activities. /li liFluent in English; French is an asset. /li /ul h3What We Offer /h3 ul liBeing part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day. /li liPartner with teams across disciplines, at the forefront of oncology and anti‑infective development. /li liAn inclusive and respectful workplace — proud to be Equal‑Pay certified. /li liGrow in a culture that values people, purpose, and performance. /li liA chance to grow, share, and shape the future of healthcare. /li /ul /p #J-18808-Ljbffr