CAI ยท 5 months ago
Quality, Compliance, and Regulatory Associate Director
United States
Full-time
Remote
Director/Executive
$130K/yr - $175K/yr
10+ years expCAI is a professional services company that provides critical solutions in high-stakes environments for the Life Sciences and Mission Critical industries. As the Associate Director within the Quality Compliance and Regulatory Practice Area, you will lead the function, ensuring excellence in service delivery while engaging in business development activities and consulting clients in Quality, Regulatory, and Compliance areas.
Asset ManagementConsultingProject Management
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
Qualification
Required
BS or higher in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related, scientific discipline
10+ 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)
Leads and mentors' teams, influencing peers and stakeholders to achieve results
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
Benefits
Comprehensive Health Insurance coverage
24 days of Paid Time Off
ESOP/401K - 15% Company Contribution (US Only)
Company paid Life Insurance
Company paid Long Term Disability
Company
CAI
CAI is a consulting company that provides technical, operational consulting, and project management services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Mike Martin
Chief Executive Officer
Phil Pursifull
Chief Financial Officer
Company data provided by crunchbase