Advisor, Quality Compliance

What Quality Compliance contributes to Cardinal Health

Quality Compliance is responsible for the development and implementation of policies, procedures and programs designed to minimize risk, enable compliant business operations, products, and services, and drive uncompromised supply chain integrity. This role provides Quality Compliance support for Cardinal Health at Home Solutions distribution centers (DC) and the Velocare business, with a focus on assigned sites and to ensure products and services comply with regulatory standards. This position will aid in driving process consistency across the network and strive for continual performance improvement with the ability to navigate in an ever-changing regulatory landscape.

Responsibilities

• Applies comprehensive knowledge and a thorough understanding of the Quality Management System (QMS).
• Supports and participates in process improvement initiatives working closely with operations leadership.
• Responsible for the implementation and execution of the QMS system with a key focus on one Cardinal Health at Home Solutions Distribution Center (DC) located in Fort Worth, Texas. 
• Focused support for Velocare (hospital-level care to the home) depots located throughout the United States by applying knowledge of the Quality Management System (QMS) and driving implementation of policies and processes.
• Ongoing support of Velocare business through follow-up
• Will contribute to the development of policies and procedures. 
• Works collaboratively on multiple projects to include new facility set-up, operations pillars for improvement, assisting business in implementing processes as a result of regulatory changes, and additional business initiatives as they arise.
• Accountable for monitoring state licensing for the Texas facility and assisting with licensure requests to include research on regulations, providing sales reports, or general license questions for the site(s) directly supported. 
• Possesses a background in regulatory inspections, accreditation, and a working knowledge of Medicare Conditions of Participation and how accreditation (CHAP) supports.
• Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters concerning FDA, ISO, federal, state, and local authorities and support during inspections to include preparation and assistance as an inspection coordinator.
• Supports DC during internal audits and mock audits and responsible for working with local operations team to investigate, identify a root-cause, and derive an effective corrective action plan.  
• Completes work independently with general guidance on new projects.  Helps team develop solutions to gaps identified in processes and provides solutions that are innovative and consistent with Quality objectives. 
• Work reviewed for purpose of meeting objectives. 
• Works well with the on-site personnel with a “team” mentality.

 
Qualifications

• 4-8 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Experience with regulatory inspections
• Able to reprioritize tasks based on an ever-changing regulatory landscape
• Within proximity or travel proximity to Fort Worth, TX
• Must be on-site 5 days per week.
• Local travel may be required.

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• May contribute to the development of policies and procedures
• Works on complex projects of large scope
• Develops technical solutions to a wide range of difficult problems
• Solutions are innovative and consistent with organization objectives
• Completes work; independently receives general guidance on new projects
• Work reviewed for purpose of meeting objectives
• May act as a mentor to less experienced colleagues

Anticipated salary range: $80,100 - $110,100