Sr. Specialist, Supplier Quality Management

Quality Assurance / Supplier Quality Management

Quality Assurance 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.

Responsibilities include : following 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 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 in regards to feedback provided from Supplier for Quality Agreement content. Approved Supplier List : qualifies suppliers in compliance with internal procedures and in compliance with regulatory requirements. Lifecycle Management : assist 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, will 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 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.). Performs other job duties as assigned.

Performance Expectations include : modeling the characteristics outlined in the Cardinal Health Leadership Essentials- Managers of People, Process, or Projects. Demonstrating a commitment to the organization's mission, vision, and values supporting organizational decisions and behaviors. Working as part of a team with others and showing respect and values diversity toward others. Demonstrating efforts to discovering, meeting, and advocating for the customer's needs. Taking actions to continually improve quality and safety in daily work. Actively participating in improving work processes to meet and exceed expectations. Identifying opportunities for improvement based on process observations, outcome measures, and feedback. Reporting errors in a timely and appropriate manner. Taking initiative and being 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. Maintaining integrity, composure, communicates with honesty, transparency, clarity, and promotes alternative perspectives.

Qualifications include : 2-4 years of experience in a regulated pharmaceutical GMP environment, preferably manufacturing preferred. 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 supplements. Works on projects of moderate scope and complexity. Identifies possible solutions to a variety of identified quality issues and takes action to resolve. Effectively interprets the requirements and communicate to upstream suppliers, colleagues, and downstream service providers to ensure prompt attention to identify quality and service-oriented solutions and / or identified quality issues. Educate the influence others on quality issues and requirements. Must be detail-oriented and very conscientious. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Experience using electronic Quality Management Systems. ASQ certification is strongly preferred. Experience auditing suppliers and / or vendors is strongly preferred. Travel up to 25%.

Anticipated salary range : $68,000 - $87,400. Bonus eligible : No. Benefits include : medical, dental, and vision coverage; paid time off plan; health savings account (HSA); 401k savings plan; access to wages before pay day with myFlexPay; flexible spending accounts (FSAs); short- and long-term disability coverage; work-life resources; paid parental leave; healthy lifestyle programs.

Application window anticipated to close : 11 / 09 / 2025. If interested in the opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills, and an evaluation of internal pay equity.