Sonja Cools Email & Phone Number

Paris, France, Fr

Ensure on time & in full delivery of products within the Rare Blood Disorder franchiseAct as a virtual plant head, representing Sanofi towards CMOs and partnership managementServe as the primary point of contact for addressing supply issues, coordinating crisis management efforts, and leading troubleshooting initiativesSupport / Lead internal and joint cross-functional Core Teams and associated +QDCI sessionsEnsure adherence to agreed-upon terms and conditions in supply agreements by both Sanofi and CMOsCoordinate and conduct regular Quality Business Reviews with CMOs according to established agreements and performance criteriaEnsure timely execution and reporting on CMO performance according to KPIs and relevant criteriaEnsure actual spend with CMO is in line with relevant budgets. Motivate deviations and capture as part of forecasting processActively support the identification of product life cycle management and process improvement initiatives at CMOsRepresent EM&S in the Industrial Product TeamFoster a positive/constructive culture of collaboration and partnership with CMOs or Partners

Paris, France, Fr

Direct a team of quality specialists to manage External Supply Quality located within the United States, Germany and Belgium supporting a product portfolio of 4 Rare Blood Disorder products, including development, clinical and commercial programs. Support proper staffing and organizational set-up to fulfill activities in compliance to Sanofi standards, regulatory requirements and international standardsProvide day to day leadership, guidance and direction to staff consistent with GxP and company quality governanceAct as a coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary actionDefine, follow-up and report-out on department KPI'sOperate in strong interface with Senior Management and product teams to routinely review/update the Site Quality and Product Roadmaps and to ensure priorities are aligned with business objectivesProvide expert support and act as interface to operational teams for significant issues, product issues and RQNs. Support authority inspections by local and international authorities

Paris, France, Fr

Responsible for the oversight of 15+ staff on a multi-shift schedule and multi-tiered leadership role consisting of QA Officers. Providing QA oversight of API manufacturing operations including deviation/CAPA management, change control, SOP/Batch Record approval, Periodic Product Review and OOS investigations.Ensured product quality by enforcing quality policies and procedures based on government requirements and international guidelines and by reviewing and approving product related protocols and reports.Developed Batch Record Right First Time and Record metrics in order to improve RFT metrics in Cell Culture, and Purification by partnering with MFG and Area +QCDILead in Lean Manufacturing and Continuous Improvement Projects (i.e.. lead time reduction Batch Record Review, implementation of 24/7 QA shop floor support, shop floor deviation handling, digital data collection in support of release dossier)Active participation in regulatory inspectionsQA representative neoGAA project in support of phase 3 clinical trial and commercial implementationMaintained quality staff job results by coaching, and counseling, planning, monitoring, and appraising job results.

Paris, France, Fr

Introduction of a new biopharmaceutical manufacturing process for the production of monoclonal antibodies (mAb). Support PAI and agency audits, leading teams, point person stakeholders and global quality.Key contributor towards the Build-out and qualification of the new fed batch production facility including design, construction, commissioning and process validation. Support of BLA submission.Winning member of the Sanofi Industrial Affairs Innovation Award 2018

Paris, France, Fr

Quality support of a fed-batch and continuous perfusion production facility. Deviation/CAPA/change handling (investigate and writing reports). Quality support during internal and external audits. Quality representative in Lean Manufacturing projects.

Start up and implementation of a new manufacturing process for the production of VISINE® (eye drops)

Oversight of production operations and planning (60+ staff), lead teams, initiation of productivity and performance management programs to meet on time delivery requirements and improvement of production levels, product quality.Support implementation of electronic batch records (IPCMD, MES) - Latina- Italy. Implemented standard work in a Grade A, B and C environment. Issue handling and support of improvement items.Support ramp up from zero to 60 employees in 3 monthsKey contributor start-up and implementation of a new manufacturing process for the production of eye drops (Visine).