Principal Consultant (Qualified Person)

We are seeking an experienced Qualified Person (QP) with strong Investigational Medicinal Product (IMP) expertise to lead GMP compliance, vendor oversight, and product release activities for a growing business.

This client-facing role involves supporting sponsors through the release of IMPs for clinical trials and ensuring full regulatory compliance across projects.

Key Responsibilities:

• Act as Qualified Person (QP) for IMPs, supporting release for clinical trials.
• Lead client meetings (weekly, bi-weekly, monthly, ad hoc) to provide project direction and updates.
• Oversee vendor qualification and GMP compliance, including QP audits and risk assessments.
• Manage GMP change controls and resolve quality risks.
• Review and advise on Quality Agreements and sponsor/QP/QP agreements.
• Support sponsor product releases to manufacturing and clinical trials.
• Provide mentorship and training to sponsors and project teams, including system transitions.

This fully remote role is perfect for someone ready to step outside their comfort zone and make a real impact within a highly reputable company.