Job Description
What is expected of you and others at this level in Quality & Regulatory Affairs for functional success
- 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 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 implications
Accountabilities in this role
- Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers
- Load and extract product systematic data on substances within Cardinal Health Master Data systems
- Review and evaluate received questionnaire forms for completeness and applicability
- Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks
- Identify and quantify risk, communicate results effectively to management
- Support management of QRA policies governing product quality data
- Identify quality and regulatory related issues within current processes, investigate and provide recommendations
- Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan.
Responsibilities
- Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health
- Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk
- Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies
- 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
Qualifications
- Bachelor's degree preferred
- 0-1 years experience preferred
- Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 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
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.
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