Senior Quality, Compliance, and Regulatory Engineer

CAI•Boston, MA

3d•$130,000 - $175,000•Remote

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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