Sr. Specialist, Quality Compliance

Cardinal Health•Dublin, OH

3d•$57,500 - $77,020•Hybrid

About The Position

Regulatory Management 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. Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health Distribution facilities as well as those of our 3PL customers. Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk. Supports the development of programs, policies and procedures using knowledge of regulatory requirements and technologies. Assesses and supports the management of risk. Works to understand 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 a broad knowledge of the technical disciplines in own functional area; 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 culture and diversity.

Requirements

Excellent verbal, written, computer, SAP, and interpersonal skills required
Excellent influencing skills
Must be able to multitask and work with competing priorities

Nice To Haves

Bachelor's degree preferred
4-6 years’ experience preferred
Knowledge of FDA regulations for prescription drugs and medical devices (21 CFR) preferred
Knowledge of State regulations for the purchase, sale and distribution of drugs and medical devices (21 CFR) preferred.
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

Responsibilities

Manage Medical Distribution Facility Licensing required to distribute drugs and devices
Manage Pharmaceutical Distribution Facility Licensing required to distribute drugs and Controlled substances
Manage 3PL partner facility and pharmacy licenses required to distribute drugs and devices
Ensures compliance with State and Federal Laws and regulations
Identify and Quantify Risk, communicate results effectively to management
Work with the Cardinal Health Legal department and State Government Boards to remain current on state and local rules and regulations for the distribution of drugs and devices. Report changes that affect CAH or 3PL partners to management.
Manage the documents governing 3PL licensing requirements
Support management of QRA policies governing 3PL distribution
Work with the 3PL partner to obtain sourcing and ensure compliance in each facility
Manage the policy governing licensing requirements
Provide support for Medical and Pharmaceutical Distribution field personnel relating to Licensing, NABP accreditation, License Tracker navigation, etc.
Identify quality and regulatory related issues within current processes, investigate and provide recommendations.
Interact with cross-functional business partners (Customers, Operations, Sourcing, State Boards of Pharmacy, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan.