Director, QA For Pharmacovigilance & Risk Management

Marlborough, MA
Jul 12, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Establishes and maintains the Global Quality System for Pharmacovigilance and Risk Management (PVRM) that supports Sunovion regional and DSP global products in compliance with ICH Guidelines and international regulatory requirements. Develops and maintains policies and procedures for the PVRM Quality System and provides Quality Assurance support for SOP’s, auditing, deviations, training and CAPA. Leads the establishment and execution of a global risk-based PVRM audit program for DSP Companies, contract vendors and third parties working closely with quality counterparts globally. Leads inspection readiness and management activities for Sunovion and coordinates global inspection readiness activities for PV inspections of global products. Collaborates with global PVRM and quality staff as well as QPPV to ensure global coordination of quality system activities. Monitors the global and regional PVRM Quality System through metrics and reports on the status of the Quality Systems to Head of Global Quality and Head of Global PVRM.