Job Description
We are looking for an experienced project manager to join a large pharmaceutical company on an initial 6-month contract.
This position is accountable for ensuring comprehensive operational preparedness ahead of the commercial launch of a new product. You will oversee and integrate all New Product Introduction (NPI) efforts, including launch execution, readiness planning, and development of product and process strategies, in collaboration with cross-functional teams at both the site level and corporate functions.
Key Responsibilities:
* Lead all operational readiness efforts related to NPI (process and analytical), working with multidisciplinary teams across Manufacturing, Engineering, Quality, MSAT, Supply Chain, and CMC.
* Manage and coordinate regulatory submissions and inspection readiness activities, including Pre-Approval Inspections (PAI).
* Proactively identify potential risks associated with new product launches and develop strong mitigation strategies to support successful Process Performance Qualification (PPQ) and ensure stable, compliant commercial production.
Technical Expertise Required:
1. Strong working knowledge of cGMP, <...