Facility Licensing Advisor

Cardinal Health

28d•Hybrid

About The Position

What Quality Compliance 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 Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. Position is expected to be a hybrid role What is expected of you and others at this level Works and make decisions independently regarding facility licensing, management of 3PL licenses, 3PL quality policy, NABP accreditation, and SAP Board of Pharmacy Table management among other responsibilities as needed. COE/Technical Expert on applicable laws and regulatory concepts utilized to manage risk for each of the following functions Pharmacy, Wholesale Distribution, 3PL, Home Patient Delivery Leads the development and maintenance of Cardinal Health state licensure regulatory programs, policies and procedures using knowledge of regulatory requirements and technologies Shares responsibility for the management of Risk with QRA leadership Understands complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces. Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results. Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications. Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources. Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity

Requirements

Bachelor's degree preferred
4-6 year experience preferred
Strong knowledge of FDA regulations for prescription drugs and medical devices (21 CFR) preferred
In depth knowledge of State regulations for the purchase, sale and distribution of drugs and medical devices (21 CFR) preferred.
In depth knowledge of State regulations for the dispensing of drugs and medical devices (Pharmacy, Home Medical Equipment Provider) preferred.
Distribution Operations processes (Medical and Pharmaceutical) preferred
Excellent verbal, written , computer, SAP, and interpersonal skills required
Excellent influencing skills

Responsibilities

SME for Regulatory State Licensure
Designated Representative Change management and high-risk/time-sensitive change submission.
Analysis of new state requirements
Analysis of regulatory changes and impact assessments.
Review 50 state requirement spreadsheet bi-annually
Overall Entity Management - make certain the facilities have the appropriate licenses
Tracker Management Requirements
Ensures teammates are also up to date on regulatory changes.
Identify quality and regulatory related issues within current processes, investigate and provide recommendations.
Corporate NABP Renewals
Facility Inspection support
Responsible for timely HSL assignment submissions
Drive continuous risk management improvement
Maintain Tracking of BOP Regulatory Matters