CAI · 1 day ago
CQV Associate Director
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.
Asset ManagementConsultingProject Management
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
Qualification
Required
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