Distribution Manager

**Brief Job Description**
- Responsible for planning and managing all aspects of Drug Substance (DS), Drug Product (DP), and Investigational Medicinal Product (IMP) distribution, returns and destruction activities for assigned clinical studies both domestic and international. The number of projects undertaken will be dependant on the services that are being managed and their complexity
- Works collaboratively internally and externally to manage and oversee activities for ‘on time in full’ delivery, such that Biopharmaceutical Development (BPD) project goals and milestones are seamlessly achieved.
- Uses import/export intelligence and depot knowledge to develop distribution strategies, and influences to ensure that any issues are managed appropriately
- Develops and follows functional policies and best practices
- Contributes to the operational effectiveness of Logistics and Clinical Supply (LCS)

**Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)**

The following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this role:

- Effectively use Distribution tools, procedures and best practices to deliver optimal shipping solutions
- Select, develop and manage distribution vendors in conjunction with Technical Manager, liaising closely to ensure accuracy of information transfer and creation/maintenance/tracking of accurate distribution plans, import/export documents, permits etc.
- Maintain and update transit lanes, documenting most effective Incoterms, Importer of Record, and harmonized tariff code selection.
- Provide input to Interactive Response Technology (IRT) system specifications for distribution, review and approve requirements, complete system specifications and participate in user acceptance testing (UAT)
- Manage and monitor all shipments and ensure timely processing of all shipment excursions where applicable.
- Ensure timely maintenance of current, accurate and complete IMP distribution records (hard copy and electronic as appropriate) enabling that all necessary files are uploaded to the product Specification File (PSF), Trial Master File (TMF) or other relevant GXP system.
- Support and manage the IMP returns process including review of returns of materials from clinical sites to aid in documenting full IMP reconciliation.
- As required coordinate distribution activities in relation to DS and/or QC sample shipments aligned to assigned projects or specified manufacturing facilities
- Maintain & expand close cross-functional relationships, negotiating and sharing information as relates to clinical distribution activities. Ensure that milestone timelines are agreed and maintained to best meet the project objectives
- Liaise closely with Quality Assurance (QA) activities with respect to clinical distribution, and as pertains to vendor selection, qualification and monitoring and all other compliance activities.
- Raise non-conformances when identified and participate in investigations to support on-time closure of deviation records
- Partner with stakeholder departments to identify critical challenges and risks associated with DS, DP or IMP distribution. Communicate and provide input into risk management plans including options and recommendation for risk mitigation
- For assigned projects represent Distribution activities in LCS Matrix and other project meetings as required. Contribution to overall supply planning, execution of distribution strategy and effective use of distribution systems for stakeholder reporting etc
- Create, or assist in the creation of departmental SOPs, work instructions, guidelines, processes and systems to support maintenance, improvement and future growth of LCS and Distribution best practice
- Attend and actively participate in departmental meetings
- Mentor, develop and generally supervise the activities of other members of co-workers (LCS staff, summer interns, rotational associates etc.) assigned to flexible roles within the Distribution team
- Effectively use Distribution tools, procedures and best practices to deliver optimal shipping solutions
- Select, develop and manage distribution vendors in conjunction with Technical Manager, liaising closely to ensure accuracy of information transfer and creation/maintenance/tracking of accurate distribution plans, import/export documents, permits etc.
- Maintain and update transit lanes, documenting most effective Incoterms, Importer of Record, and harmonized tariff code selection.
- Provide input to Interactive Response Technology (IRT) system specifications for distribution, review and approve requirements, complete system specifications and participate in user acceptance testing (UAT)
- Manage and monitor all shipments and ensure timely processing of all shipment excursions where applicable.
- Ensure timely maintenance of current, accurate and complete IMP distribution records (hard copy and electronic as appropriate) enabling that all n