Ph3Job Title /h3 pCSQ Senior Associate, Quality Systems – Risk Management /p h3Job Location(s) /h3 pBeerse, Antwerp, Belgium and Latina, Italy (Requisition Number: R- ). Switzerland (R- ). The Netherlands (R- ). /p h3Job Description Summary /h3 pEnforces quality requirements, establishes quality systems for new technologies, reviews development data, approves master clinical production records and executed records, sets inventory status, delivers training on standard operating procedures, approves investigations and supports activities related to regulatory submissions and inspections. /p h3Role Purpose /h3 pThe CSQ Senior Associate, Quality Systems – Risk Management is a key contributor to the Clinical Supply Quality organization, responsible for coordinating and overseeing quality systems with a strong focus on risk management, governance, and quality oversight in support of clinical trial supplies. /p pThe role ensures compliance with GMP, quality, regulatory, and internal compliance requirements and partners closely with cross‑functional stakeholders to maintain inspection readiness and drive continuous improvement. /p h3Key Responsibilities /h3 ul liPrepare for and participate in quality governance and oversight meetings (e.g., QOR, GGB, QSMR) as assigned. /li liCollect, monitor, analyze, and present key quality metrics and risk‑based indicators in accordance with established procedures. /li liLeverage digital and AI‑enabled tools, where approved, to support: ul liTrend analysis and metrics evaluation /li liRisk identification and data review /li liDrafting and reviewing quality documentation (with appropriate QA oversight) /li /ul /li liDevelop and maintain trend analyses (e.g., monthly/quarterly trend reports) to identify systemic risks and improvement opportunities. /li liProvide insights and recommendations to Quality Systems management to support risk‑based decision‑making. /li liAttend and/or lead operational oversight meetings (e.g., NC and Change Control focus teams). /li liEnsure consistent application and integration of quality systems across clinical supply activities. /li liWhen needed, provide hands‑on support across other Quality CoEs, including NC/CAPA, Change Control, Training Documentation, Inspections Audits processes. /li /ul h3Required Qualifications /h3 ul liBachelor’s degree in Life Sciences or a related field. /li liMinimum 5 years of experience in an FDA and/or EMA regulated pharmaceutical, biotech, or clinical manufacturing environment (RD experience is an asset). /li liStrong working knowledge of: ul liGMP and quality systems /li liRisk management, deviation, CAPA, and change control processes /li liQuality governance and metrics trending /li /ul /li liFamiliarity working with digital and AI‑enabled tools to support data analysis, documentation, and quality system activities, with a clear understanding of validation, compliance, and data integrity expectations. /li liAbility to operate effectively with minimal supervision and manage multiple priorities. /li liProven capability to lead complex quality issues and drive resolution across stakeholders. /li liFluent knowledge of English language. /li /ul h3Preferred Qualifications Skills /h3 ul liFamiliarity with quality systems such as COMET, SUMMIT, TruVault, VMP and other analytical tools. /li liExperience working in data‑driven or digitally enabled quality environments. /li liStrong analytical, problem‑solving, and communication skills. /li liAbility to work effectively in a matrix, cross‑functional, and global environment. /li /ul h3Why Join CSQ /h3 ul liBe part of a high‑impact clinical supply quality organization. /li liContribute to risk‑based quality governance supporting early‑ and late‑phase clinical development. /li liGain exposure to multiple Quality Centers of Excellence and global quality systems. /li liWork in a collaborative environment focused on quality excellence and continuous improvement. /li /ul h3Additional Skills /h3 ul liProject Quality. /li liQuality Services, Quality Standards. /li /ul /p #J-18808-Ljbffr