Pharma Project Manager

Senior Systems Project Manager / Senior Program Manager

Job Introduction: We are seeking an experienced Senior Program Manager to lead the delivery and implementation of critical manufacturing and quality systems, including MES, CSV, and EMS, within a fast-paced, high-visibility pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can drive execution across cross-functional teams, proactively manage risk and ambiguity, and ensure projects are delivered on time, with quality, compliance, and strong stakeholder alignment.

Senior Program Manager Responsibilities:

Lead end-to-end project delivery across MES, CSV, and EMS initiatives

• Manage project scope, schedule, budget, risks, and dependencies
• Drive coordination between IT, Quality, Manufacturing, and external vendors
• Ensure all systems and processes align with GxP and regulatory expectations
• Oversee validation activities, including planning, execution, and documentation
• Facilitate issue resolution and decision-making across stakeholders
• Provide clear and consistent status reporting to leadership
• Support integration efforts across manufacturing and enterprise systems
• Maintain strong governance and change control throughout the project lifecycle

Job Requirements:

Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field

• 7–12+ years of project management experience in life sciences or regulated industries
• Proven experience delivering MES implementations (e.g., PAS-X, Syncade, Opcenter, etc.)
• Strong background in CSV and validation methodologies (CSA preferred)
• Experience with EMS platforms and integration into manufacturing environments
• Experience with SAP and other Enterprise platforms
• Demonstrated ability to operate in fast-paced, high-pressure environments
• Strong stakeholder management and communication skills
• Experience managing vendors and system integrators
• Familiarity with GxP, 21 CFR Part 11, and data integrity requirements
• Experience supporting greenfield or startup manufacturing environments preferred
• Exposure to biologics, cell and gene therapy, or similar advanced modalities preferred
• PMP or equivalent certification preferred