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 :
* 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 recognized 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.
* Support the PAL with quality systems, knowledge management, service definition, and delivery in your area of expertise.
* Fulfill Quality, Regulatory, and Compliance roles while managing client relationships, ensuring alignment with project schedules and stakeholder expectations.
* Engage in strategic project work that enables broader team deployment or complements larger initiatives with specialized expertise.
* Build and maintain strong relationships with EU regulatory authorities and other stakeholders to ensure access and influence.
* Develop and mentor CAI agents through professional development plans and initiatives.
Position Requirements :
* Work Environment : Hybrid role with on-site presence as needed across European client sites.
* Education : Bachelor’s, Master’s, or PhD in relevant scientific disciplines, with industry experience.
Experience :
* Minimum of 10 years in the life sciences industry with leadership or collaboration experience.
* Deep knowledge of cGMP, Quality Assurance, regulatory affairs, and pharmaceutical manufacturing.
* Experience in sterile manufacturing, biotech, medical devices, or Cell and Gene Therapy is advantageous.
* Proven in developing and implementing Quality Management Systems.
Skills / Competencies :
* Leadership & Mentorship
* Clear communication and collaboration skills
* Sound decision-making and business acumen
* Self-motivated with strong organizational skills
* Expertise in EU and international data regulations
* Technical knowledge of cGMP and quality systems
* Problem-solving and adaptability
* Strong relationship-building skills
Other Requirements :
* Willingness to travel domestically and internationally within Europe
* Eligibility to work in the EU without visa sponsorship
Salary: €133,000 - €153,000 annually.
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