QA Operations Lead

Posté 01 September 2021
Salaire73000€ - 91000€ an + 15% BONUS
VilleLes Ulis, Île-de-France
Type de poste CDI
SecteurScientifique
RéférenceBBBH477264_1630488471

Descriptif


- Leadership of team of >30 associates. Leadership of several teams within QA Ops operations
-Ensure compliance to cGxP standards for products within Cell and Gene Therapy manufacturing and testing site (during development, transfer and commercialization) and product release.
- Operational excellence
- Provide guidance, support and leadership to teams within area of responsibility.
- Leadership of team of >30 associates. Leadership of several teams within QA Ops operations
-Ensure compliance to cGxP standards for products within Cell and Gene Therapy manufacturing and testing site (during development, transfer and commercialization) and product release.
- Operational excellence
- Provide guidance, support and leadership to teams within area of responsibility.

Major accountabilities:

  • Ensure QC and manufacturing activities executed according to cGxP standards

Ensure aseptic oversight

  • Collaboration in GxP audits/inspections
  • Oversight of Quality Operations across site
  • MBR review and approval
  • Product release
  • QA for Quality Control & AS & T
  • QA Operational Excellence