Advisor, Quality Compliance

Responsible for the implementation and execution of the Cardinal Health Quality System for the following sites including any annexes or associated locations:

• Fife, Washington Medical Distribution
• Portland, Oregon including At Home and Velocare
• Anchorage, AK Medical Distribution

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 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 to implement new company procedures or update existing procedures to facilitate compliance.
• Serves as liaison with local, state, accreditation and federal government agencies.

• Coordinate and manage QRA-related activities throughout the facility by:
• Investigate non-conformances with QRA policies and report to Corp QRA, vendors, business partners and other leadership groups, as necessary (FDA)
• Document the event utilizing the current NCR/CAPA system
• Investigate, coordinate investigation, or follow-up for closure of customer complaints and provide response to Corp QRA or another designated group.
• Oversee compliance with established procedures
• Function as the facility POC for agency or internal QRA inspections
• Oversee facility training programs (FDA, DOT, etc.) and work with local trainers to ensure training completions
• Assist with licensure requests to include research on regulations, providing sales reports, or answering general license questions
• Quality support required for the Velocare (hospital in home) program
• May be responsible for the quality process at multiple facilities.

• Facilitate temperature monitoring for all assigned storage locations as required by procedure
• Review and authorize monthly temperature records to ensure completion and accuracy
• Coordinate calibration of temperature monitoring equipment; maintain and verify appropriate records are maintained.
• Draft, implement and conduct training on the facility plans
• Temperature Contingency Plan, Site Security Plan
• Facilitate reporting and management of temperature excursions and other situations involving execution to Contingency or Security plans.
• Ensure that quarterly reviews of badge access, master key disbursement and after-hours access reports are completed by the facility Security Coordinator.
• Coordinate annual security alarm tests and quarterly alarm tests for refrigerators and freezers (and if necessary warehouse areas, as directed by Corp QRA).
• Ensure documentation is complete and filed accordingly.
• Oversee or coordinate the facility on-call list. Manage or coordinate any changes/updates with local Security company. Ensure that facility alarm system is adequately set for emergency doors and after-hours conditions
• Coordinate with on-site Facilities team (if applicable) preventative maintenance activities for all equipment utilized at the facility
• HVAC
• Refrigerator (as applicable)
• Freezer (as applicable)
• Dock doors and plates
• Generator
• Roof
• Water heaters
• Other equipment as defined by QRA policy
• Coordinate with on-site team to develop and maintain a listing of equipment and systems that require a preventative maintenance program.
• Conduct facility temperature studies as required to maintain compliance to applicable regulations (NABP, BoPh)

• Oversee facility process to ensure product is maintained and stored according to required storage requirements, including temperature, protect from light, upright storage, cube, debris, out of location product, etc.
• Coordinate with appropriate facility personnel non-compliant with storage requirements
• Develop and implement a corrective action plan to prevent recurrence.
• Ensure that the facility does not ship expired product
• Periodically verify that expired product is appropriately tagged and moved into quarantine areas as soon as possible after discovery
• Ensure there are designated product storage areas for all product status types (FCA, Quarantine, Hold, Discard, etc.).
• Facilitate and/or organize facility housekeeping program.
• Dust protection
• Sterile barrier inspections
• Contamination of Value Link totes
• Facilitate pest control program ure…