Senior Project Manager - Onsite (Cell and Gene Therapy)

Location: United States; onsite

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Coordinate commissioning, qualification, and turnover activities required for facility occupancy and operational readiness.
• Coordinate contractors, stakeholders, and the Engineering Project Manager to resolve issues and maintain project momentum.
• Maintain integrated project schedules, tracking milestones, dependencies, commitments, and critical-path activities.
• Maintain project controls, including issue and risk logs, action-item tracking, communications plans, governance materials, and status reports.
• Facilitate governance and stakeholder meetings, document decisions, and monitor follow-through on commitments.
• Use knowledge of cell and gene therapy processing to identify risks and support CQV and EMPQ execution.

Requirements

• Experience providing project management leadership, coordination, communication, and project execution support.
• Knowledge of commissioning, qualification, and validation activities for processes and facilities.
• Knowledge of cell and gene therapy processing.
• Ability to manage schedules, project controls, risks, issues, dependencies, and stakeholder communications.
• Ability to support operational readiness and facility occupancy objectives.

Culture & Benefits

• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment encouraging innovation, collaboration, and entrepreneurship.
• Remote work is supported by the organization, while this role is identified as onsite.
• Applications are personally reviewed by the recruitment team without AI screening tools.
• Candidates receive an outcome after application review.