The Role
Serve as a CQV subject-matter expert and discipline lead providing strategic CQV consulting, client and project oversight across multiple sites, business development, mentorship, and technical guidance on commissioning, qualification, validation, QRM, automation integration, and digital validation strategies.
Summary Generated by Built In
Are You Ready?
CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Mission Critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.
Our approach is simple because our Purpose informs everything we do:
•We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
At CAI, we are committed to living our Foundational Principles, both professionally and personally:
•We act with integrity
•We serve each other
•We serve society
•We work for our future
At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing
expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.
Position Overview:
The CQV Associate Director, also known as a Discipline Lead (DL) is a recognized CQV subject matter expert, who can act in a project oversight role, to include managing client relationships for particular projects or at a site, and can do that for multiple sites simultaneously. Engages in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver special expertise. Works for and reports to the CQV Global Director. Supports the client project teams. The person would also be available as an internal source of knowledge in support of proposals and our internal qualifications, or in response to the needs of our teams across the globe for such expertise remotely.
Key Responsibilities:
1. Subject Matter Expertise & Strategic Leadership
•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.
2. Client & Project Oversight
•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.
3. Business Development & Industry Engagement
•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.
4. Mentorship & Internal Development
•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.
5. Technical Consulting Expertise
•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.
Qualifications and Experience:
•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.
Critical Competencies
Influence Strategy
•Evaluates and pursues initiatives, opportunities, and priorities based on fit with organization strategies.
•Identifies innovative solutions to challenges that have strategic impact, balancing both short- and long-term concerns.
•Identifies issues related to emerging customer and market needs.
Satisfy the Customer
•Identifies and anticipates customer requirements, expectations, and needs.
•Develops solutions that meet or exceed customer expectations and shares feedback with relevant groups.
•Consistently follows up with customers to resolve issues and maintain customer satisfaction and loyalty.
•Continually searches for ways to improve customer service, including removal of barriers and providing solutions.
Plan for Success
•Translates business/function strategies into aligned plans and objectives and integrates across business groups.
•Obtains and allocates resources needed to accomplish goals.
•Anticipates risk and builds effective contingency plans.
Pursue Execution
•Prioritizes and balances time, actions, resources, and initiatives to ensure achievement of critical goals.
•Holds self and others accountable for achieving outcomes.
•Anticipates obstacles and takes appropriate actions to accelerate work or improve quality.
Tailor Communication
•Communicates information clearly, concisely, and professionally.
•Tailors communication style and content to audience effectively.
•Writes technical concepts clearly and thoroughly for all audience types.
Build Partnerships
•Cultivates a network of people across a variety of disciplines and functions within the organization.
•Builds collaboration by identifying and conveying common interests and priorities, removing barriers, and breaking down silos.
•Appropriately involves others in decisions and plans that affect them.
•Maintains positive relationships regardless of challenges, organizational level, personality, or background differences.
Influence Others
•Develops and articulates compelling rationale for positions.
•Builds a broad base of support among key decision makers and influencers.
•Positions and explains ideas and proposals in ways that get support from others.
•Encourages others to find new solutions that improve outcomes and deliver value.
Develop Self and Others
•Continuously develops interpersonal skills to build effective internal and external relationships.
•Models company values and always acts with integrity.
•Looks for opportunities to develop breakthrough ideas and initiatives.
#LI-MV1
Benefits
Our full-time positions offer competitive compensation and benefits which include: 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 as well as 70% long term disability paid for by the company.
Top Skills
Cqv,Qrm,Automation Integration,Digital Validation Life Cycle,Aseptic Fill/Finish,Osd,Gene Therapy,Life Science Manufacturing Processes
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The Company
What We Do
Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience. We are 800+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location. Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance. When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.
