Senior Manager Quality Assurance Inspection Readiness

Job title : Senior Manager Quality Assurance Inspection Readiness
Location : Les Ulis, Île-de-France Region
Job type : Permanent
Salary : £75000.00 - £85000.00 per annum
Contact name : Yannick Baroue
Contact email : yannick.baroue@secpharma.com
Act as the Primary Point of Contact in Quality for entities or individuals involved in preparation, conduct and post regulatory inspections.
Support interface with Global quality Audit for non-Clinical, Clinical, Pharmacovigilance audits.
Lead Inspection Readiness (IR) activities for Ipsen entities covering GLP, GCP, GVP, including Pre and Clinical Activities, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
Lead Pre-Approval Inspection (PAI) activities, identify Quality Risks and provide strategic solutions for continued improvement across the concerned activities.
Leads transversal projects that support inspection readiness for which significant changes/improvements to business processes are expected across R&D and beyond
Act as a quality contact during partners PV audits