Global Director of Commissioning, Qualification, and Validation
Location: United States | Employment Type: Full Time
CAI is a professional services company established in 1996 with a global footprint of nearly 800 professionals. We empower mission‑critical industries to achieve accelerated operational readiness and excellence in highly regulated environments.
Position Overview
The Director, CQV Center of Excellence (Commissioning, Qualification & Validation) is a global leadership role responsible for driving business growth across commissioning, qualification and validation for equipment, facilities, computers, processes and cleaning systems. The role provides client support and consulting to life sciences customers, develops skill‑building programs, and delivers market‑leading strategies to expand our service footprint.
Key Responsibilities
- Service Quality & Operational Excellence
- Establish and support quality systems for all practice activities and engage senior‑level clients on high‑visibility projects.
- Develop and publish procedures, guidelines, tools and templates to ensure repeatable, efficient execution.
- Mentor internal agents to build internal capabilities.
- Talent Management & Team Development
- Collaborate with Training to customize qualification programs for the practice.
- Recommend industry conferences and external training to support skill development.
- Assist in developing internal training to support service delivery.
- Industry Engagement & Market Positioning
- Drive thought leadership, industry engagement and marketing support.
- Actively participate in marketing events.
Other Responsibilities
- Proposal support and bid defense
- Industry presentations
- Marketing plan development
- Participation on professional society committees
- Regional agent engagement with RM/CM routine activities
- Agent training sessions
- Mentoring and coaching of staff
- Qualification cards development
- Lead the Community of Practice (CoP)
- Capture lessons learned for project closeout support
- Comply with internal objectives and performance metrics
Required Skills & Qualifications
- Bachelor’s degree in a scientific or technical discipline (preferred).
- Experience in pharmaceutical manufacturing or R&D site operations.
- Deep understanding of OR/OE strategies and life sciences quality requirements.
- Familiarity with enabling technologies such as CMMS and MES.
- Excellent facilitation and virtual meeting skills.
- Exceptional verbal communication and presentation abilities.
- Active connections within pharmaceutical industry forums.
- Global perspective with the ability to navigate cultural and geographic differences.