Senior Quality, Compliance & Regulatory Strategist

Cagents; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

CAI is seeking a Senior Quality, Compliance, and Regulatory Engineer to lead the Practice Area, drive excellence in service delivery, and advance operational readiness across regions. You will shape quality systems, guide regulatory strategy, and collaborate with clients and CAI agents on complex projects.

In this role, you will mentor teams, manage client relationships, and contribute to content development for thought leadership.

Qualifications

• 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).

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

Skills

Leadership

Communication

Decision-Making

Business Acumen

Drive

Regulatory & Data Compliance

Technical cGMP

Learning Agility

Problem-Solving

Relationship Building

Education

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

Job description

CAI is seeking a Senior Quality, Compliance, and Regulatory Engineer to lead the Practice Area, drive excellence in service delivery, and advance operational readiness across regions. You will shape quality systems, guide regulatory strategy, and collaborate with clients and CAI agents on complex projects.

In this role, you will mentor teams, manage client relationships, and contribute to content development for thought leadership.