We’re looking for an experienced Qualified Person (QP) to provide QP certification, quality leadership, and compliance oversight across Crinone® commercial operations. You’ll ensure batches are released in line with UK legislation, cGMP, and the Orange Guide, while supporting projects, audits, and continuous improvement across the business.

The Role:

• Certify commercial batches in accordance with UK legislation and product licences.
• Ensure all manufacturing meets cGMP and Orange Guide requirements.
• Provide Quality, compliance, and regulatory guidance to the Crinone Quality team.
• Review BMRs, deviations, and key PQS processes (Change Control, CAPA, QA agreements, etc.).
• Conduct internal/external GMP audits and support client/regulatory inspections.
• Oversee contractor and supplier performance through site visits and business reviews.
• Contribute to Product Quality Reviews and manage any Product Recalls.
• Support materials management, risk assessments, and QA leadership activities.
• Lead CI projects and ensure safe working practices.