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CAI · 3 months ago

Operational Readiness Project Manager

United States

Full-time

Remote

Mid, Senior Level

$140K/yr - $175K/yr

3+ years exp

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.

Asset ManagementConsultingProject Management

No H1B

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

Qualification

Operational ReadinessContinuous ImprovementProject ManagementLean Six SigmaStakeholder ManagementGMP RegulationsCoaching SkillsCommunicationTeam LeadershipProblem SolvingTechnical WritingCollaboration

Required

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