Senior Manager Quality Assurance Inspection

Job title : Senior Manager Quality Assurance Inspection
Location : Les Ulis
Job type : Permanent
Salary : €75000 - €85000 per annum
Contact name : Yannick Baroue
Contact number : +44 (0) 207 255 6650
Contact email : yannick.baroue@secpharma.com
*Leads the development of Inspection Readiness and Pre-Approval Inspection preparation with respective team leaders from business functions and applicable co-development partners and service providers

*Provides required leadership and support pre, during and post regulatory agency sponsor inspection with the goal to ensure Inspection Team (IT) and Rapid Response Team (RRT) are trained through mock interviews, and able to reply during questioning for a sponsor PAI or any other inspection in related field

*Defines and develops strategies to work with cross-functional departments to improve "inspection readiness" and consistently identify and mitigate clinical quality risks

*Develop and obtain quality-driven, risk-based metrics, evaluate and report metrics and trends to ensure internal and external adherence to inspection readiness expectations

Education / Certifications:
*Master's degree or higher in relevant scientific life science
*10 years in international pharmaceutical quality assurance function, including at least 6-8 years' experience in GxP Quality System, GCP clinical and / or GCP Quality operations related roles, pharmacovigilance
*Thorough knowledge and understanding of Global regulatory requirements, knowledge of GCPs, ICH requirements, understanding pharmacovigilance requirements and industry standards
*Extensive knowledge of Research & development with past experience in clinical operations, preferably global clinical trial management, pharmacovigilance and global GCP and GVP inspections.

Experience:
*Experience with FDA, EMA, MHRA or other regulatory inspections of sponsor, investigator sites, service providers
*Ability to multi-task and to prioritize assignments in accordance with assigned project deadlines
*Strong facilitation skills and team leadership: lead complex projects/assignments through discussions on complex and potentially controversial topics; bring consensus among diverse cross functional teams, interpersonal and communication skills (written and verbal)

Languages:
*Fluent English and French