Joint Process Team Leader

Job Description

Responsibilities JPT Leader role is the externally facing business owner for the relationship between Lilly and a contract manufacturer (CM). He is reporting to the Senior Director of Operations OUS and serve as a link between the JPT and the DPEM Lead Team as a core member of the Flow Team. Location : India Affiliate (frequent visit at CM site required) Key Objectives/Deliverables: Support On-Going CM Operations by providing leadership and oversight at the Join Process Team Leads cross-functional JPT, between Lilly and CM, to develop and implement strategically aligned Quality and Supply Plans and the Technical Agenda for the CM. Accountable for the governance process over the CM and the monitoring of business, quality, safety and technical metrics, identifying areas of concern or risk, generating CAPA s and improvement plans and timely escalation of issues. The Joint Process Team Leader ensures that the process team is operating as an effective, well-balanced team and can make appropriate science-based decisions. The Joint Process Team Leader acts as an integrator and has accountability of all aspects of joint process team results which includes: First point of escalation on issues from CM to Lilly. Assist with all issues related to the CMOs manufacturing process including but not limited to Quality, HSE events, facilities, equipment, training, trend analysis and self-monitoring. Recognize when issues are beyond the technical capabilities of the JPT and when to request additional technical assistance. Escalating issues to the appropriate management level when necessary, following the appropriate notification to management process. Owning the change and improvement agenda of the JPT. Manage production, batch release and shipment schedules to ensure appropriate resources are available to meet objectives. Frequent visit at CMs site Assuring that the process team understands the process economics and how the decisions impact the plant financial scorecard. The Joint Process Team Leader could be responsible for more than one joint process team CM relationship. Has awareness of contract requirements. Ensures that the MRD is in place and relevant aspects of the contracts are being adhered to by Lilly and the CM. Assist TS/MS, Quality and Supply Chain personnel with timely completion of APR, OPV, SCR, Quality Agreement, PV/PPQ protocols and reports and MRDs, as necessary. The Joint Process Team Leader is aware of procurement and compliance regulations. The Joint Process Team Leader knows the Operational Control Strategy for CMs processes. Ensuring that the JPT is conducting Root cause Analysis and Failure Mode and effect Analysis (FMEA) with the CMs. The Joint Process Team Leader acts consistently with the Lilly values and the Team Lilly expectations and serve as positive role model for their Process Team and the organization The Joint Process Team Leader leads the internal Operational Process review (iOPS) with the DPEM Lead Team according to the annual calendar. Assist local affiliate with management of their product portfolio as required. Relationship with CM: Make frequent visits (on weekly basis) at CM location (India) to maintain strong working relationship. Key expert for operations Manage conflicts and problem resolution. Facilitate Lilly/CM Steering Team meeting agendas, with issues from the JPT requiring Steering Team actions and drive action closure. Support external and internal audits performed at the CM related to Lilly product portfolio. Relationships: All key relevant functions at the contract manufacturers Lilly Affiliate personnel and senior Country and Area management Drug Product External Manufacturing leadership Lilly Manufacturing Procurement Network within Lilly manufacturing sites to support role and relationship . .