Hybrid Associate Director, QCR

Posted last month

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About the role

  • 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)

Job title

Associate Director, QCR

Job type

Experience level

Senior

Salary

€133,000 - €153,000 per year

Degree requirement

Bachelor's Degree

Location requirements

HybridIreland

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