The Outsourcing Coordinator drives the design, packaging and labeling of high quality clinical supplies for studies worldwide, for external packaging through third-party contractors. He/she uses his/her expertise in design, labeling and packaging execution to convert the needs of the clinical demand into compliant packaging designs. He/she takes the lead and ownership of the Operational meeting to ensure all the deliverables are met to achieve GMP release on time.
• Ability to manage complex compound portfolio (for example: pooled studies, accelerated timelines, high tech devices, frozen platform, products that require exceptional packaging processes and storage conditions, …).
• He/she takes the lead and ownership of the Operational meeting to review packaging orders to ensure all the deliverables are met to achieve GMP release on time. He/ she will work directly with the TSM and take the lead in communicating with all other functions within CSC about on time delivery, required actions and status of the P&L orders. He/she will escalate potential missed timelines through this meeting and determine possible solutions to minimize impact.
• Manage projects with packaging vendors, negotiating timelines, overseeing project progress to ensure timely release and distribution of the clinical material to depots
• Develop strong internal collaboration within the CSC and influencing stakeholders to improve services, cost or lead time.
• Create and maintain individual project agreements (IPA) between CSC and P & L vendors.
• Indicate label needs on the sharepoint site enabling the Label Coordinators to start preparing the label design in a timely manner.
• Review and approve relevant parts of source documentation (IMPA).
• Maintain detailed knowledge of packaging designs, components, label requirements, randomizations, systems, end-to-end processes, regulatory, GCP and GMP requirements.
• Take leadership role on training of P & L OC new hires on the outsourced P&L processes within outsourcing coordinator functions and team members of the operational meeting.
• Provide expertise at operational meetings on packaging designs, label process, label requirements and packaging execution. Influence IMPA owner in taking decisions in line with packaging standards and processes. Act as a single point of contact between the team, the Label Coordinator, CSI, TSM and the P & L vendor.
• Constantly strive for innovation to increase efficiency and reduce timelines. Participate actively in global initiatives to optimize processes and tools in line with the Process Excellence Methodology.
• Develop compliant, user-friendly packaging designs in conjunction with the MST P & L group for implementation at the vendors, and internal partners in accordance with the trial design
• Utilize the randomization specifications to create project specific kit lists. Ensure the generated files are transferred to the necessary recipients.
• Convert all data with regards to the trial design, packaging design, labeling and randomization into packaging element trees and kit assembly flows. Manage packaging orders in SAP and NGEN CODAC.
• Communicate finished goods details (e.g. quantity, ranges, etc) to the Clinical Design Integrator or the Trial Supply Manager.
• Manage events, deviations and CAPAs and implement process improvements (route cause analysis, corrective and preventive actions, impact assessment, organize training, update SOPs)
• Conduct issue resolution activities for P & L aspect of clinical studies.
• Initiate and oversee outsourced packaging projects with external vendors:
- Facilitate pre-and post packaging approvals and obtain release through Quality Assurance.
- Act as J&J’s primary point of contact for P & L vendors by maintaining good working relationships and communication with the contractor, other CSC functions, QA, AD and other business partners.
- Responsible for vendor set up of the financial aspects including vendor quotes, PO’s and invoicing.
- Assist periodically in monitoring contractor performance.
• Take a lead role in overseeing all aspects of a P & L site, be the main contact for all issues at the site for the vendor and OC’s.
• Ensure a pro-active follow up on the progress of the project to assure timely release and escalation of potential missed timelines to management along with solutions to minimize impact to study.
• Process improvement: stream line OC process: ensure OC documentation (IPA) is continuously evaluated to ensure documentation can be efficiently used by internal OC & external partners.
• Has knowledge of the capabilities for primary and secondary packaging and labelling, blistering and bottling capabilities and ambient, cold and frozen storage capacity.
• Can identify optimizations and/or changes to processes and to existing equipment and follows up on testing and documenting changes.
• Take ownership to initiate root cause investigation in case of issues and defining corrective actions with support of Janssen CSC experts.
• Setting up P&L process with new vendor and work with them to have better, more efficient and aligned way of working.
• Manage and support process changes (flex use of Ngencodac); connect with OC and IT in order to implement aligned changes successfully. Be involved in audits & audit preparation in collaboration with vendor & QA as need
• Facilitate on audits and audit preparedness in collaboration with QA and vendor if applicable.
• Coordinate relabeling activities at sites and depots.
Profile needed for this function
• Bachelor’s degree in scientific field or equivalent through experience. Generally, requires 5-10 years of related or relevant experience.
• Knowledge of inventory management systems
• Experienced in GMP, GCP, GDP and or quality management systems or processes.
• Knowledge of planning systems and contractor project plans
• Knowledge in Office applications (MS Word, MS Excel, MS PowerPoint)
• Good communication skills, able to collaborate with different departments (e.g. ESI DP, Outsourcing Coordinators, Logistics, CSI / T&SM and Procurement.
• Ability to work independently
• Result and performance driven
• Project management skills
• Big picture orientation with attention to details
• Strong analytical skills managing complexity and identifying process gaps.
• Strong organizational skills
• Ability to communicate complex issues and solutions to business partners
• Influencing and negotiating skills
• Ability to work in cross a functional and cross-cultural environment
• Experience in clinical packaging and operations is preferred
Bachelor’s Degree or Equivalent (Requirement)
Specific know how of systems
• Knowledge of planning systems
• Knowledge of procurement tools
• Knowledge SAP functions related to this function
• Basic knowledge in Office applications (MS word , MS excel , MS power point)