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The Position is Hybrid, not 100% remote (many projects will require on-site presence)
Position Description:
As the Associate Director within the Quality Compliance and Regulatory Practice Area 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 across Europe, ensuring excellence in service delivery, operational readiness, and execution.
This role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions in Europe. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth.
The Associate Director will report directly to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR).
Specific responsibilities include:
•As a leader, 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 engagements, article writing, and participation in professional society committees; support the development of standards or guidance documents within these groups.
•Possess a network of industry contacts who would recognise you as an expert in Quality and Compliance.
•Create and contribute to content that supports industry-leading approaches, enhancing CAI’s website and marketing materials.
•Consult clients in the areas of Quality, Regulatory, and Compliance.
•Provide significant support to the PAL with respect to quality systems, knowledge management, service definition, and delivery in your area of expertise.
•Fulfil Quality, Regulatory, and Compliance roles while managing client relationships for a portfolio of products, ensuring alignment with project schedules and stakeholder expectations.
•Engage in strategic project work that opens the door to broader team deployments or complements larger initiatives with specialised expertise.
•Build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders to ensure access and influence.
•Develop and mentor CAI agents through structured professional development plans and initiatives.
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Position Requirements:
•Work Environment: Hybrid role with on-site presence required as needed across European client sites.
•Education: Bachelor’s, Master’s, or PhD in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related scientific discipline, combined with relevant industry experience.
Experience:
•Minimum of 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.), 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 devices, and/or Cell and Gene Therapy is highly advantageous.
•Demonstrated technical leadership in the development and implementation of Quality Management Systems (QMS).
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Skills/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 organisation. Gathers relevant information, asks insightful questions, and collaborates to identify optimal solutions.
•Business Acumen: Delivers quality work, identifies improvement opportunities, and simplifies processes.
•Drive: Demonstrates initiative, self-management, and strong organisational skills.
•Regulatory & Data Compliance Expertise: Knowledgeable in EU and international data regulations, ensuring integrity, security, and compliance.
•Technical & cGMP Expertise: Skilled in cGMP environments, covering manufacturing practices and quality systems.
•Learning Agility & Problem-Solving: Adaptable, resolves issues effectively, plans independently, and works well in teams.
•Positive Influence: Identifies and addresses problems, takes initiative, seeks feedback, and drives continuous improvement.
•Relationship Building: Maintains strong relationships at all levels, shares knowledge, and collaborates constructively.
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Other Requirements:
•Able to travel domestically and internationally across Europe as required
•Able to work in the EU without visa sponsorship now or in the future
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