Advisor, Quality Compliance

Cardinal Health•Columbus, OH

1d•$82,100 - $105,480•Onsite

About The Position

Regulatory Management develops and deploys policies, procedures, and programs designed to minimize risk, enable compliant business operations, products, and services, and drive uncompromised supply chain integrity. The Advisor, Quality Compliance demonstrates knowledge of regulatory requirements and uses their experience to assess regulatory changes, risks, and business impacts. The role is responsible for implementing and executing the Cardinal Health Quality System at the Ohio Valley distribution center in Columbus, Ohio. It assesses and improves Quality Management System (QMS) implementation to enhance performance and supply chain integrity while preserving and optimizing system efficiency. The Advisor provides guidance to operations personnel on regulatory and quality matters and serves as a liaison with local, state, and federal government agencies. This position works closely with Operations Leadership, LSS, and other functional groups to develop policies and procedures, recommend improvements to quality and regulatory programs, lead non-conformance and CAPA investigations, drive quality metrics, and lead or participate in audits and QMS projects. The role reports to a Manager, Quality Compliance and is full time onsite at the Ohio Valley Distribution Center.

Requirements

Bachelor’s degree in a related field or equivalent work experience is preferred.
At least 4 years of experience in a related field is preferred.
Knowledge of applicable regulatory requirements.
Experience with multiple regulatory entities or regulations, such as 21 CFR Parts 205 and 820, FDA, BOP, and NABP, is desirable.

Nice To Haves

CQA or other quality auditing experience.
Bachelor’s degree in a related field or equivalent work experience.
At least 4 years of experience in a related field.
Experience with multiple regulatory entities or regulations, including 21 CFR Parts 205 and 820, and organizations such as NABP.

Responsibilities

Implement and execute the Cardinal Health Quality System at the Ohio Valley distribution center.
Assess QMS implementation to drive performance improvement, enhance supply chain integrity, and optimize system efficiency.
Assess regulatory changes, risks, and business impacts.
Provide ongoing guidance and direction to operations personnel on regulatory and quality matters.
Serve as liaison with local, state, and federal government agencies.
Participate in the development of policies and procedures to achieve specific goals.
Work with Operations Leadership, LSS, and other functional groups to initiate and drive change.
Recommend new practices, processes, metrics, or models related to quality and regulatory programs.
Lead non-conformance and CAPA investigations using Root Cause Analysis techniques and develop sustainable corrective actions.
Drive quality metrics and ensure processes are followed.
Lead or participate in quality system audits and QMS projects as directed.
Independently determine methods for completing new projects and provide solutions that may set precedent.
Drive culture change and enhancement within facilities.
Perform other duties as assigned.