Description

Significant experience with audits and inspections both in Pharma and Medical devices ( FDA, Anvisa, KFDA, GCC, PMDA, SwissMedic, Notified Bodies (TUV, BSI, Dekra). Long experience with Commissioning, Qualification, validation work at manufacturing sites. Talent for investigation and problem-solving techniques / tools. Expert in QMS agile development at local (site) and global level (BU, Corporate).

Strong communication and leadership skills in Global multicultural / matrix environments. Capacity to listen, engage people, drive changes and shape organization. Problem solver, results oriented, unlocking Team potential to deliver pragmatic solutions in complex technical and human working environment.

Languages

French
Native or bilingual

Workplace preferences

Can work on-site

Genève (up to 50km)

Self Employed
Senior Quality Consultant
January 2022 - Today (4 years and 5 months)
Geneva, Switzerland
Current assignment: QMS set up & Harmonisation across several manufacturing sites (ISO9001, ISO13485, cGMP). eQDMS tool deployment. Development of a QC reference Lab. Guidance on process and cleaning validation.
SABATICAL LEAVE
Time for a Change!
January 2021 - January 2022 (1 year)
Switzerland
Becton Dickinson
Director Quality International Infusion
January 2020 - January 2021 (1 year)
Accountable for Quality function for "Medication Management Solutions - Infusion systems" Business unit. Leading and developing Quality organisation for the different locations (60 associates on 5 sites). Developing, implementing strategies for Quality system and products quality improvement.