[Remote] CQV Associate Director
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/.