Senior Project Manager

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:

• Strong working knowledge of cGMP, FDA regulations, and international pharmaceutical manufacturing and quality standards.
• Proven experience applying Process Analytical Technology (PAT), ASTM standards, and 21st Century cGMP principles.
• Familiarity with ICH Q8, Q9, Q10, and Q11, and their application in a regulated environment.
• Experience with CMC and regulatory submission processes, including NDAs and MAAs.
• Understanding of differing global regulatory perspectives on Quality by Design (QbD) and their impact on regulatory strategy and submissions.
• Broad knowledge of regulatory compliance, validation, and inspection readiness.
• In-depth understanding of product development lifecycles, cross-functional development teams, and project governance processes.