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 (such as change controls, SCARs, Risk Assessments, and Quality Agreements) 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.

• Negotiate suppliers Quality Agreements commitments prior to QRA Management approvals (by ensuring preparation of the adequate documentation) of the agreement.
• As a member of the Quality Supplier Management Program, will evaluate suppliers in compliance with Good Manufacturing Practices and regulatory requirements.
• Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
• Reviews, comments and challenges in an appropriate way, the Quality Reviews for the supplier’s quality agreements status.
• Understands technical supplier issues and evaluate 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 meeting related to his/her area of responsibility (suppliers meeting, , change control, audits planning and review, budget, etc.)
• Addressing CAPA’s from external audits.
• Conducting a management review (for suppliers) of the quality system.
• Following-up on and closing pending preventive and corrective action requests.
• 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.
• The ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.
• Travel – up to 10%.

• 2-4 years of experience preferred
• BA, BS or equivalent experience in related field preferred
• Reports to Supplier Quality Management (QRA).
• Demonstrates knowledge of supplier quality /quality systems and approaches.
• Demonstrates an understanding of the relevant FDA regulations, standards and operating procedures for supplier qualifications.
• Demonstrates knowledge of Supplier Quality as it…