Sr. Specialist, Quality Compliance

Cardinal Health; Dublin (OH); Hybrid; USD 58,000 - 77,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Health savings account

401k plan

Early wage access

FSAs

Disability coverage

Work-life resources

Parental leave

Wellness programs

Job summary

Cardinal Health in Dublin, OH is seeking a Regulatory Management professional to lead licensing, policy deployment, and risk assessment across medical and pharmaceutical distribution. You will collaborate with Legal, state boards, and field teams to ensure compliant operations and supply chain integrity.

The role requires knowledge of FDA regulations (21 CFR), state licensing requirements, and strong communication.

Qualifications

• Bachelor's degree preferred.
• Knowledge of FDA regulations for prescription drugs and medical devices (21 CFR) preferred.
• Experience in regulatory compliance and risk management.

Responsibilities

• Manage Medical Distribution Facility Licensing to distribute drugs and devices.
• Manage Pharmaceutical Distribution Facility Licensing for drugs and controlled substances.
• Ensure compliance with State and Federal laws and regulations.
• Identify and communicate risk to management.
• Collaborate with Legal and State Boards to stay current on regulations.
• Support 3PL licensing requirements and licensing policy governance.
• Interact with cross-functional partners to execute the Quality Plan.

Skills

FDA regulations knowledge

Regulatory compliance

Multitasking

Communication skills

Interpersonal skills

Education

Bachelor's degree preferred

Tools

SAP

Job description

What Regulatory Management contributes to Cardinal Health

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 than 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

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.

Qualifications

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

Location

• Hybrid role, looking to be on site in Dublin 3 days a week

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 actions to resolve
• Applies judgment within defined parameters
• Receives general guidance may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range:

$57,500 - $77,020

Bonus eligible:

No

Benefits:

• 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

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.