Note: The job is a remote job and is open to candidates in USA. CAI is a professional services company that provides operational readiness and performance solutions for mission-critical and regulated industries. The CQV Associate Director will act as a subject matter expert in CQV, managing client relationships and overseeing projects across multiple sites while supporting strategic initiatives and internal development efforts.

Responsibilities

• Acts as a recognized subject matter expert (SME) in CQV across multiple sites and projects
• Provides high-level consulting on best-in-class CQV practices, including risk-based approaches and program assessments
• Supports strategic project work as a door-opener or specialized expert
• Reports directly to the CQV Global Director and serves as a knowledge resource internally and externally
• Manages client relationships across multiple sites or projects
• Participates in or leads the initiation and early stages of billable CQV projects
• Oversees internal programs with cross-functional teams, including client personnel and contractors
• Drafts and reviews CQV proposals and estimates for clients
• Engages in forums, publishes articles, participates in committees, and influences guidance standards
• Builds and maintains a network of industry contacts to identify new opportunities and increase value to current clients
• Supports the proposal process and helps grow CAI's business pipeline
• Mentors employees and develops qualification and training materials
• Acts as an internal CQV knowledge base for teams across the globe
• Contributes to internal qualifications, knowledge sharing, and process improvements
• Advises on integrated commissioning and qualification strategies
• Implements QRM methodologies and assesses supplier qualifications
• Consults on facility, equipment, utility CQV methods, including automation integration
• Supports digital validation life cycle and strategies for accelerating project delivery and speed to market

Skills

• BS or MS in a relevant science or engineering field, or equivalent
• Seven (7) or more years in CQV SME or project manager for large CQV projects roles for life sciences. Demonstrated success in leading your team to achieve defined goals
• Excellent oral and written communication skills in English
• Excellent skill in leading teams to perform complex tasks under pressure
• Excellent problem-solving skills
• Customer-service focused
• Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
• Able to travel domestically and internationally if required

Benefits

• Up to 15% retirement contribution
• 24 days PTO and 5 sick days per year
• Health insurance at extremely low cost to employee
• Financial support for both internal and external professional education
• 70% long term disability paid for by the company
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• ESOP/401K - 15% Company Contribution (US Only)
• Company paid Life Insurance
• Company paid Long Term Disability

Company Overview

• CAI is a consulting company that provides technical, operational consulting, and project management services. It was founded in 1996, and is headquartered in Indianapolis, Indiana, USA, with a workforce of 501-1000 employees. Its website is https://cagents.com/.