Sr. Principal Specialist, Risk Management

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 improvement initiatives.
• Develops proactive approaches to identify, scientifically evaluate, and control potential risk to quality, which could be a structured gap assessment/internal audit, review of industry observations, trends and other information.
• Participates in review of Annual Product Reviews.
• Develops metrics to identify trends and/or acute issues, which will be utilized to engage management review for Investigations, SCARS, CAPAs, etc., as needed
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Represents QA in meeting related to his/her area of responsibility
• Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.
• Assists with Field Alert Reports (FARs) and Product Recalls, when required.
• Role models Cardinal Health's high ethical standards and code of conduct and models the characteristics outlined in the Cardinal Health Leadership Essentials- Managers of People, Process, or Projects.
• Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
• Performs other job duties as assigned.

Experience

• 4-8 years of experience in a regulated pharmaceutical GMP environment, manufacturing preferred.
• BA, BS or equivalent experience in related field preferred
• Critical investigations and gap assessment experience preferred
• Applies working knowledge in the application of quality systems concepts, principles, and technical capabilities to perform varied tasks.
• Strong proficiency in  the relevant FDA regulations, standards and operating procedures in particular drugs and dietary supplements.
• Demonstrates an understanding of the requirements and can perform gap assessments to those requirements. 
• Identifies p