Sr. 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.

The Sr. Specialist, supplier quality management executes quality programs, policies, and procedures in a particular area of specialty to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due to a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.

• Follow standard operating procedures for 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: prepares and/or reviews audit reports, ensures adequacy of supplier responses to audit observations, and assesses qualification state of Supplier. May conduct or participate in audits.
  • Quality Agreements: reviews, comments and challenges in an appropriate way regarding feedback provided from Supplier for Quality Agreement content.
  • Approved Supplier List: qualifies suppliers in compliance with internal procedures and regulatory requirements.
  • Lifecycle Management: assists with ongoing monitoring and oversight of supplier quality performance (i.e., through metrics, trending SCARs, etc.).
• As a member of the Quality Supplier Management Program, evaluate suppliers in compliance with Good Manufacturing Practices and regulatory requirements.
• Ensures quality system documents (i.e., change controls, nonconformances, and CAPAs) for which the team is responsible are followed and closed within defined timelines.
• Understands technical supplier issues and evaluates their potential impact on product quality and compliance.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Represents QA in meetings related to his/her area of responsibility (suppliers meeting, change control, audits planning and review, budget, etc.).
• Performs other job duties as assigned.

• Models the characteristics outlined in the Cardinal Health Leadership Essentials
  - Managers of People, Process, or Projects.
• Demonstrates a commitment to the organization’s mission, vision and values supporting organizational decisions and behaviors.
• Works as part of a team with others and shows respect and values diversity toward others.
• Demonstrates efforts to discovering, meeting and advocating for the customer’s needs.
• Takes actions to continually improve quality and safety 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.
• 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.
• Has the ability to act…