Full timeEngineering

Senior Quality, Compliance, and Regulatory Engineer

CagentsBoston🇺🇸United States

Quick overview

Salary$130k - $175k/yr

SeniorityMid Senior

Employment typeFull Time

Work modeHybrid

LocationBoston, United States

Job description

Are You Ready?

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.

Job Summary:

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.

Job Requirements:

1. Business Development & Industry Engagement:

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.

2. Strategic & Expert Consulting

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.

3. Knowledge Leadership & Thought Contribution

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.

4. Talent Development

Develop and grow agents through tailored professional development plans and initiatives

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)

Leadership Competencies:

Leadership & Mentorship:

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

Communication Skills:

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

Decision-Making:

· 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 

Business Acumen:

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

Drive:

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

Regulatory & Data Compliance Expertise:

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

Technical & cGMP Expertise:

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

Learning Agility & Problem-Solving:

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

Positive Influence:

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

Relationship Building:

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

#LI-MV1

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. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FCO.

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