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.
- Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
- Leads and directs efforts to assess the implementation of Quality and EH&S Management Systems to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency.
- Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements.
- Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance.
- Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters.
- Monitors Federal, State, and local regulatory activities in order to implement new Company procedures or update existing procedures to facilitate compliance.
- Serves as liaison with local, state and federal government agencies.
This Compliance Manager will handle the East coast region.
- Manages FDA inspection management for all the PET manufacturing sites
- Ensures sites are ready for FDA inspections
- Interacts with regulatory agencies as necessary
- Prepares and submits Field Alert Reports or Product Recalls to the FDA.
- Initiates Health Hazard Evaluations
- Prepares and submits FDA 483 responses and monitoring commitments to completion.
- Coordinates submission of corporate audit responses with site management and monitoring commitments for completion
- Manages overall complaint process management and coordination of Adverse Event reporting with Regulatory Affairs
- Travels for various PET manufacturing sites as needed (up to 50% of the time)
- Other duties as assigned
- Bachelors in related field, or equivalent work experience, preferred
- 8+ years experience in related field, preferred
- 3-5 years of experience in a cGMP environment and in a quality management role strongly preferred
- Pharmaceutical manufacturing knowledge required. PET drug manufacturing preferred.
- Must have the ability to travel for business up to 50% of the time
- Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements.
- Excellent interpersonal, organizational and communication skills.
- Demonstrated leadership skills
- Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
- Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.
What is expected of you and others at this level
- Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
- Participates in the development of policies and procedures to achieve specific goals
- Recommends new practices, processes, metrics, or models
- Works on or may lead complex projects of large scope
- Projects may have significant and long-term impact
- Provides solutions which may set precedent
- Independently determines method for completion of new projects
- Receives guidance on overall project objectives
- Acts as a mentor to less experienced colleagues
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.