Hélène Coulot-Lehoux Email & Phone Number

Switzerland

Genève, Suisse

• To lead and drive the quality management of the allocated CMO portfolio, ensuring:o Effective and efficient quality oversighto Appropriate quality decisions are made and communicatedo Efficient coordination of all operational quality matters (investigations, deviations, changes, CAPAs etc.), acting as the Single Quality Point of Contact within cross-functional CMO management team for all CMO-related topicso Implementation of state-of-the start governance, procedures, processes, tools and ways of working, including quality reviews.o Identification and effective implementation of continuous quality improvement planso Effective quality support and guidance, including support to investigations or regulatory inspections where neededo Appropriate Quality metrics to monitor CMO performance are defined, implemented and communicated to the organizationo Appropriate identification, assessment, prevention and mitigation of riskso Effective quality coordination of product/process transfer/introduction projectso Proper oversight of CMO operations including e.g. validations• To work closely and effectively liaise with other entities and functions • To participate to external audits• To act as quality representative within project • To lead cross-functional initiatives• To act a deputy RP in Switzerland for batch release

Genève, Suisse

• Management: direct report: 5• Responsible for quality oversight of the product manufacturing, supply and distribution including supplier management.• QMR Deputy (Qualified person)• Manage batch release• Manage quality processes: Change control, CAPA, Deviation, Documentation, Audits, Training• Perform Management Review and monitor quality processes• Directly Manage Notified Body audit (MDSAP) and inspections (TGA, Corée)• Perform external audits (Distributors) and internal audits.• Perform quality training• Provide QA support with the life cycle management projects

Ecublens Vd, Canton De Vaud, Suisse

Gaillard, France

- Management team: 9 people- Manage batch release- Handle deviation and CAPA- Perform internal audit- Define annual quality training- Define and handle quality metrics

Crissier Switzerland

- QA Manager (team of 7 persons)- Ensure the conformity of the QMS- Development and implement Monthly Quality metrics- Prepare and perform authorities audit (FDA,swiss medic,ANVISA, TÜV, Russia.. ): FDA inspection in 10/2013 without any 483- Handle deviation and CAPA within TrackWise system- Pilot change control system, complaints and supplier audits- Is in charge of improvment system

Crissier Switzerland

- QA Manager Deputy- Handling of deviation- Project leader for documentation improvement (SOP, master batch record)- Handling of customer complaint

Evreux France

- QA Manager- Release of batch- Handling of customer complaint- QA supervision and handling of quality systems(change control, deviation, documentation)- Development and implementation of Quality system KPI - Responsible for audit

Romainville France

Docteur En Pharmacie

Dea National De Toxicologie, Toxicologie