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.

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$130,000 - $175,000 a year

Average salary range, not including benefits or compensatory time and possible discretionary bonuses.

CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.