Operational Readiness Project Manager

CAI Overview

Are You Ready?

CAI is a professional services company established in 1996 that has grown to over 700 people worldwide. We provide program and project management, commissioning, qualification, validation, start-up, and other consulting services associated with operational readiness and operational excellence to FDA-regulated and other mission-critical industries.

We put our clients’ interests first, we do not stop until it is right, and we will do whatever it takes to get there.

At CAI, we are committed to living our Foundational Principles

• We act with integrity
• We serve each other
• We serve society
• We work for our future

We believe that with employee ownership, one person’s success is everyone’s success. We embrace a Team Before Self mindset, demonstrate Respect for Others, and maintain a Can-Do Attitude-our three core values.

Position Overview

The Operational Readiness Project Manager (ORPM) serves as a strategic leader bridging the gap between mechanical completion and sustained operational performance. The ORPM designs and leads holistic Operational Readiness programs using CAI’s six-pillar Readiness Framework. This role ensures project teams achieve right-first-time metrics, foster a culture of continuous improvement, and deliver world-class performance from day one.

Key Responsibilities

• Project & Program Leadership
• 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.
• Pillar Integration & Execution
• 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).
• Client Advisory
• Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.).
• Guide decision-making with a risk-based, speed-to-value mindset.
• People Development
• Lead and coach cross-functional teams including CQV, Quality, and external contractors.
• Cultivate a culture of feedback and growth.
• Thought Leadership
• Contribute to CAI's brand via white papers, conference presentations, and client tools.

Skills & Characteristics Required

• Consulting & Facilitation
• Align project stakeholders with clear vision and measurable goals.
• Expert-level guidance for site and department leadership.
• Project Execution
• Manage scheduling, resource loading, controls, and closeout.
• Execute comprehensive project planning and delivery.
• Continuous Improvement
• Drive site-wide transformation using Lean, Six Sigma, or TPM methodologies.

Qualifications and Experience

• 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.

(Black Belt or equivalent preferred.)

• 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.

Other Requirements

• 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.
• PMI PMP or PgMP certification a plus.

Critical Competencies

Influence Strategy

• Evaluates and pursues initiatives, opportunities, and priorities based on fit with organization strategies.
• Identifies innovative solutions to challenges that have strategic impact, balancing both short- and long-term concerns.
• Identifies issues related to emerging customer and market needs.

Satisfy the Customer

• Identifies and anticipates customer requirements, expectations, and needs.
• Develops solutions that meet or exceed customer expectations and shares feedback with relevant groups.
• Consistently follows up with customers to resolve issues and maintain customer satisfaction and loyalty.
• Continually searches for ways to improve customer service, including removal of barriers and providing solutions.

Plan for Success

• Translates business/function strategies into aligned plans and objectives and integrates across business groups.
• Obtains and allocates resources needed to accomplish goals.
• Anticipates risk and builds effective contingency plans.

Pursue Execution

• Prioritizes and balances time, actions, resources, and initiatives to ensure achievement of critical goals.
• Holds self and others accountable for achieving outcomes.
• Anticipates obstacles and takes appropriate actions to accelerate work or improve quality.

Tailor Communication

• Communicates information clearly, concisely, and professionally.
• Tailors communication style and content to audience effectively.
• Writes technical concepts clearly and thoroughly for all audience types.

Build Partnerships

• Cultivates a network of people across a variety of disciplines and functions within the organization.
• Builds collaboration by identifying and conveying common interests and priorities, removing barriers, and breaking down silos.
• Appropriately involves others in decisions and plans that affect them.
• Maintains positive relationships regardless of challenges, organizational level, personality, or background differences.

Influence Others

• Develops and articulates compelling rationale for positions.
• Builds a broad base of support among key decision makers and influencers.
• Positions and explains ideas and proposals in ways that get support from others.
• Encourages others to find new solutions that improve outcomes and deliver value.

Develop Self and Others

• Continuously develops interpersonal skills to build effective internal and external relationships.
• Models company values and always acts with integrity.
• Looks for opportunities to develop breakthrough ideas and initiatives.