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.

Job Summary

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 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

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 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

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.

Qualifications

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 interpret 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%.

What is expected of you and others at this level

Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks

Works on projects of moderate scope and complexity

Identifies possible solutions to a variety of technical problems and takes action to resolve

Applies judgment within defined parameters

Receives general guidance and may receive more detailed instruction on new projects

Work reviewed for sound reasoning and accuracy

Manages professional employees and / or supervisors; may manage business support, technical or production staff. Applies expertise to improve effectiveness and provide guidance to employees in own area.

Has accountability for managing financial resources. Manages budget for own area and allocates resources, accordingly, applying knowledge of profit drivers within own area / job family.

Role models Cardinal Health's high ethical standards and code of conduct.

Recognizes development needs and capability gaps in own area and arranges specific projects / assignments to address needs.

Builds confidence and respect of others through a positive and energizing style.

Interprets internal / external business issues and adapts work priorities in own area.

Works with customers to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others.

Effectively solicits and explains difficult concepts and persuades others to adopt a point of view, states own point of view.

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.

and / or projects

Gains consensus from various parties involved parties involved

Anticipated salary range : $68,000 - $87,400

Bonus eligible : No

Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

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 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.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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