Senior Quality, Compliance, and Regulatory Engineer

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical 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.

As the Senior Quality, Compliance, and Regulatory Engineer at CAI, you will serve as both a strategic leader and subject matter expert. You will be responsible for building, expanding, and leading the Practice Area function, ensuring excellence in service delivery and operational readiness and excellence. 

This role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth. 

 

Work collaboratively with CAI agents to sell QCR services and deliver strategic project work

Leverage your professional network to attract new business opportunities, generate leads, and secure assignments for consultants through proactive and targeted sales efforts 

Engage in industry forums, speaking, writing articles, participating in professional society committees, support standards or guidance document creation within such groups

Build and maintain strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence. 

 

Consult clients in Quality, Regulatory, and Compliance areas

Fulfill Quality, Regulatory and Compliance roles, while managing client relationships for a portfolio of products and being responsible for close liaison with the management/ other key personnel in line with time frames per the project schedule.  

Engage 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 specialized expertise.

 

Create and contribute to content in industry-changing approaches that will benefit CAI web site and marketing materials. 

Provide significant support to PAL with respect to quality systems, knowledge management, services definition, and delivery in your area of expertise. 

 

Develop and grow agents through tailored professional development plans and initiatives

 

BS or higher in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related, scientific discipline.

8+ years' experience in the life sciences industry with a proven track record of leading or collaborating effectively within cross-functional teams.

In-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments. 

Prior experience in sterile manufacturing, biotechnology, medical device, and/or Cell and Gene is highly advantageous. 

Demonstrated technical leadership in the development and implementation of a Quality Management Systems (QMS) 

 

·       Leads and mentors’ teams, influencing peers and stakeholders to achieve results. 

·       Communicates clearly, writes technical documents, presents business ideas, and fosters collaboration. 

·       Makes sound, timely decisions that benefit the team and broader organization. Gathers relevant information, asks insightful questions, and works with peers to identify optimal solutions  

·       Delivers quality work, finds improvement opportunities, and simplifies processes.  

·       Shows initiative, self-management, and excellent organizational skills. 

·       Knowledgeable in local and international data regulations, ensuring integrity, security, and compliance. 

·       Skilled in cGMP environments, covering quality manufacturing, production practices, and systems. 

·       Adaptable, resolves issues effectively, plans independently, and collaborates well. 

·       Addresses problems, takes action, seeks feedback, and promotes continuous improvement. Influences outcomes positively. 

·       Maintains strong relationships at all levels, shares knowledge, and communicates constructively. 

 

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