Project Team Lead

Description

• Take end-to-end responsibility for launch and transfer projects from assignment to submission.
• Form and lead the project team consisting of Novartis and CMO team members, manage the team and set priorities for project and project team meetings.
• Manage project team activities necessary for project success.
• Support the evaluation of new CMOs and external suppliers for launch and transfer projects. Prepare project plans including activities at Novartis and CMOs and ensure adherence to the plan.
• Ensure that all project activities at Novartis and CMOs follow global and local GMP regulations and adequate HSE standards.
• Ensure timely availability of manufacturing processes, analytical methods, validation documents, source data and documents for registration.
• Provide input into overall ESO strategy.
• Assess resource requirements at Novartis and CMOs and request additional resources if applicable (e.g. personnel and investments). Proactively communicate critical issues to project stakeholders at Novartis and CMOs.
• Highlight potential impacts on overall project timelines, demand and supply. Make sure that issues are investigated, solutions are found and implemented.
• Ensure the documents being part of the project documentation are prepared, approved, stored and archived according to current Novartis processes and in high quality.
• Support preparation, review and approval of relevant registration documents.
• Initiate (transfers) and support the pre-approval inspection (PAI) process together with QA.
• Attend project governance and project meetings (e.g. PRM, DMC, TRD Sub team Meetings) and present the project status, or project issues, if appropriate.
• Contribute to process improvement and optimization initiatives (TLCM projects).
• Ensure that the API and Drug Product manufacturing and Drug Product packing produced after successful launch or the pharmaceutical manufacturers to produce drug products can use transfer.
• Lead and support resolution of technical issues at CMOs and external suppliers.
• Supports Launch Site decisions (CPIC) by providing analysis of technology, capacity, skills through inter-functional evaluations.

Qualifications

Highest qualification: University

• Technical transfers activities are executed on time and products meet quality requirements.
• Products and processes at assigned CMOs are in control and capable and maintained in a validated state. Completes remediation activities in accordance with project timelines.
• Defines and delivers product quality improvements.
• Ensures key projects such as Launches or Finished Dosage Form (FDF) changes are delivered on time, on budget and meet the target success criteria. Recognized as an excellent collaborator and partner by the CMOs, SRTs, QA and others partner functions (R&D).