Sr. Principal Specialist, Risk Management Position Available In Kennebec, Maine

Sr. Principal Specialist, Risk Management at Cardinal Health in Augusta, Maine, United States Job Description What Quality Assurance / Supplier Quality Management contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary The Senior Principal Specialist, executes programs, policies, and procedures within the area of quality to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Principal Specialist supports the Manager, Quality Assurance in overseeing the deviation process, CAPA and Risk Management activities. Through this program, the Senior Principal Specialist develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Principal Specialist mentors junior Specialists. Responsibilities + Develop and streamline risk management procedures by working closely within the QRA team and across various business departments to oversee and cultivate robust risk management framework. + Develop, and/or enhances, and maintains department standard operating procedures in order to ensure regulatory compliance, align to industry standards, streamline processes, and implement risk management processes. + Oversee, trains and mentors the contract laboratory, contract repackaging, and internal investigations teams. Reviews investigations for adequacy to drive identification of root causes, systemic corrections and continuous improvement initiatives. + As part of investigation outcome or identified continuous improvement initiatives, implements and/or collaborates with colleagues to drive CAPA implementation in order to enhance process improvements. + Performs root cause analysis, develops and provides input on specific and systemic corrections to drive continuous improvement. + Monitors for industry trends, regulatory guidances and regulatory expectations to identify compliance gaps and/or continuous impro