Build, expand, and lead the Quality Compliance and Regulatory Practice Area across Europe.
Serve as both a strategic leader and subject matter expert; report directly to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR).
Participate in business development activities including marketing, direct sales, and sales support across various regions in Europe.
Design and implement systems, processes, and initiatives that drive sustainable business growth.
Work collaboratively with CAI agents to sell QCR services and deliver strategic project work.
Leverage professional network to attract new business opportunities, generate leads, and secure assignments for consultants.
Engage in industry forums, speaking engagements, article writing, and participation in professional society committees; support development of standards or guidance documents.
Create and contribute content to support industry-leading approaches and CAI’s marketing materials.
Consult clients in Quality, Regulatory, and Compliance and manage client relationships for a portfolio of products.
Provide significant support to the PAL on quality systems, knowledge management, service definition, and delivery.
Engage in strategic project work that opens broader team deployments or complements larger initiatives with specialised expertise.
Build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders.
Develop and mentor CAI agents through structured professional development plans and initiatives.
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.
Minimum of 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.)
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).
Demonstrated track record of leading or collaborating effectively within cross-functional teams.
Able to travel domestically and internationally across Europe as required
Able to work in the EU without visa sponsorship now or in the future
Benefits
Hybrid working arrangement (on-site presence required as needed)
Opportunities for professional development and mentorship
Industry engagement opportunities (speaking, article writing, committee participation)
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