Operational Readiness Project Manager
- Raleigh, North Carolina, United States
- Raleigh, North Carolina, United States
Über
CAI Overview:
Are You Ready?
CAI is a 100% employee-owned 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
Sprachkenntnisse
- English
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