Hybrid CQV Associate Director

at CAI

• Job title: CQV Associate Director
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• CQV Associate Director overseeing multiple CQV projects and providing subject matter expertise. Building client relationships and supporting strategic project engagements in life sciences.

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.

Requirements

• 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 will be required. There will be significant travel to the US as part of this role.

Benefits

• We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company.