OverviewThe Associate Director within the Quality Compliance and Regulatory Practice Area at CAI is a strategic leader and subject matter expert responsible for building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution. The role is hybrid (on-site as required) across European client sites and involves active participation in business development, including marketing, direct sales, and sales support. The Associate Director reports to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR).ResponsibilitiesCollaborate with CAI agents to sell QCR services and deliver strategic project work.Leverage your 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.Maintain a network of industry contacts who recognize 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 Quality, Regulatory, and Compliance areas.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 doors to broader team deployments or complements larger initiatives with specialized 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.Position RequirementsWork 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 related scientific discipline, plus relevant industry experience.Experience: Minimum of 10 years in life sciences (Pharma, Medical Device, Biotech, etc.) with a track record of leading or collaborating within cross-functional teams; in-depth knowledge of cGMP systems, QA, regulatory affairs, pharmaceutical manufacturing, and testing; direct experience in manufacturing environments. Prior experience in sterile manufacturing, biotechnology, medical devices, and/or Cell and Gene Therapy is advantageous. Demonstrated leadership in developing and implementing Quality Management Systems (QMS).Skills & CompetenciesLeadership & Mentorship: Leads and mentors teams, influencing peers and stakeholders to achieve results.Communication: Clear written and verbal communication, technical documentation, and collaboration facilitation.Decision-Making: Gathers relevant information, asks insightful questions, and defines optimal solutions.Business Acumen: Delivers quality work, identifies improvements, and simplifies processes.Drive: Initiative, self-management, and strong organizational skills.Regulatory & Data Compliance Expertise: Knowledge of EU and international data regulations, ensuring integrity and compliance.Technical & cGMP Expertise: Proficiency in cGMP environments and quality systems.Learning Agility & Problem-Solving: Adaptable, proactive problem-solver who works well in teams.Positive Influence: Proactive issue identification, feedback seeking, and continuous improvement Drive.Relationship Building: Maintains strong relationships at all levels and shares knowledge constructively.Other RequirementsWillingness to travel domestically and internationally across Europe as required.Ability to work in the EU without visa sponsorship now or in the future.Compensation€133,000 - €153,000 per year
#J-18808-Ljbffr