Senior Quality, Compliance, and Regulatory Engineer
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
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.
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.
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.
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.
Literature
Demonstrated technical leadership in the development and implementation of a Quality Management Systems (QMS).
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.
Positive Influence: Addresses problems, takes action, seeks feedback, and promotes continuous improvement.
Relationship Building: Maintains strong relationships at all levels, shares knowledge, and communicates constructively.
Company Culture
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace.
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.
Benefits
Comprehensive Health Insurance coverage
24 days of Paid Time Off
Company paid Life Insurance
Company paid Long Term Disability