• Provide direct supervision to GSRS Quality Managers and/or Associates to set GSRS strategy and oversee day-to-day tasks related to GSRS compliance, Audit, and CAPA activities
• Partner with assigned process owners within R&D to work as their quality resource to manage quality issues, process improvement opportunities, and other quality related tasks
• Collaboratively manage the GSRS audit and inspection readiness activities, for their assigned areas, and work with Pharmacovigilance subject matter experts (SME) to evaluate systems for compliance, prepare SME for audit interviewing, and create storyboards
• Manage GSRS audit response process
• Oversee GSRS compliance activities including metric development
• This position may also be required to perform other activities within the GSRS Quality organization to achieve department objectives
• Provide input on Quality risks/decisions across Global Development
• Oversee the tracking and management of GSRS quality and compliance metrics as well as the development of new or updated metrics and quality dashboards / reports for dissemination to Senior Leadership and partners.  This includes working with members in and outside of GSRS to establish methods to gather data needed for new metrics that are developed.
• Responsible for overseeing accurate and on-time completion of Pharmacovigilance and Regulatory related Quality Issue and CAPA records for responsible areas. 

• Knowledge of Post-Marketing and Clinical Trial Pharmacovigilance regulations and direct experience in GCP, GVP, or GMP regulations
• Strong management skills, and ability to effectively lead and collaborate with various business functions
• Ability to manage multiple, competing priorities
• Demonstrated leadership, problem solving, and conflict resolution skills
• Leadership of Cross-functional initiatives/effective change management of process or technical improvements that improve department standards or practices
• Ability to establish effective business relationships with external stakeholders, including implementing process change
• Ability to influence without authority
• Excellent written and oral communication skills

All your information will be kept confidential according to EEO guidelines.