Sr. Principal Specialist, Supplier Quality 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 Supplier Qualification Program.  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

• Oversee and participate in the overall Supplier Qualification Program and Lifecycle Management of Suppliers for Cardinal Health Pharmaceutical Private Label, consisting of the following:  (1) Risk Assessment Program, (2) Audit Program, (3) Maintenance of Quality Agreements, and (4) Maintenance of the Approved Supplier List.
  • Risk Assessments:  Gathers and/or verifies data obtained from various regulatory and internal sources to determine Supplier risk profiles.
  • Audit Program:  Develop annual audit schedules, review audit reports, ensure adequacy of supplier responses to audit observations, and assess qualification state of Supplier.  May conduct or participate in audits.
  • Quality Agreements:  Reviews, comments and challenges in an appropriate way, feedback provided from Supplier for Quality Agreement content.
  • Approved Supplier List:  Qualifies supplies in compliance with internal procedures and in compliance with regulatory requirements.
  • Lifecycle Management:  Ongoing monitoring and oversight of supplier quality performance (i.e. through metrics, trending SCARs, etc.)
• Developing metrics for Suppliers to identify positive or adverse trends and/or identifying acute issues, which will be utilized to engage management review for suppliers, as needed.
• Enhances the current Supplier Corrective Action Report (SCAR) process and updates SOPs by identification of major and/or critical gaps to the Quality Agreement.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.  Receives general guidance and may receive more detailed instruction on new projects
• 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.
• Takes actions to continually improve quality in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.

• 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, preferably manufacturing.
• BA, BS or equivalent experience in related field preferred
• Applies working knowledge in the application of supplier quality /quality systems concepts, principles, and technical capabilities to perform varied tasks.
• Demonstrates an understanding of the relevant FDA regulations, standards and operating procedures for supplier qualifications including, but not limited to drugs, medical devices, and dietary