Operational Readiness Project Manager

CAI is a 100% employee-owned professional services company that provides consulting services associated with operational readiness and operational excellence to FDA-regulated industries. The Operational Readiness Project Manager will lead project teams, manage client engagements, and ensure successful delivery of readiness programs while fostering a culture of continuous improvement.

Responsibilities:

• Lead project teams to achieve Operational Readiness (OR) objectives
• Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously
• Drive on-time, on-scope delivery of readiness programs
• Serve as the primary consultant for OR campaigns integrating with Quality, Process, and Workforce streams
• Apply OE principles to pre-Day One activities (e.g., visual management, accountability, problem-solving)
• Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.)
• Guide decision-making with a risk-based, speed-to-value mindset
• Lead and coach cross-functional teams including CQV, Quality, and external contractors
• Cultivate a culture of feedback and growth
• Contribute to CAI's brand via white papers, conference presentations, and client tools

Requirements:

• BS or MS in a relevant science or engineering field (or equivalent)
• 3+ years as a program/project manager on life science projects ($1MM+), or 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/OE transformations
• Proven multi-site or multi-client portfolio experience
• Deep understanding of quality systems, tech transfer, equipment qualification, and analytics
• Excellent communication, leadership, and stakeholder management skills
• Proficient in project management software tools
• Excellent written and verbal English communication
• Able to work in the U.S. without sponsorship now or in the future
• Domestic and international travel may be required
• Willing to work overtime when necessary
• (Black Belt or equivalent preferred.)
• PMI PMP or PgMP certification a plus
• BS or MS in a relevant science or engineering field (or equivalent).