Senior QA Delegate – Clinical Supply Quality

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a senior QA associate to strengthen the Product Quality Management - Clinical Supply Quality team at Janssen Pharmaceutica NV. The role focuses on quality oversight of complex clinical supply chains, including release and certification of investigational medicinal products used in worldwide trials.

You will ensure GMP/GDP compliance, support CAPA investigations, and act as a QA expert during Health Authority inspections and audits.

Qualifications

• University degree, Industrial Pharmacist – EU certified Qualified Person is a must.
• At least 3 years’ experience in pharmaceutical supply chain and/or quality assurance.
• Experience in product release is an asset.

Responsabilités

• Perform batch release for clinical trial material in scope of the IMP license.
• Collaborate with CSC groups and global departments to obtain inputs for timely release and QP certification.
• Represent QA Clinical Supply Chain in teams to embed clinical supply quality needs from early trial stages.
• Provide coaching and training to operational departments on quality and compliance.

Connaissances

Release responsible

Quality systems

cGMP

Formation

Qualified Person (EU certified)

Description du poste

Johnson & Johnson Innovative Medicine is seeking a senior QA associate to strengthen the Product Quality Management - Clinical Supply Quality team at Janssen Pharmaceutica NV. The role focuses on quality oversight of complex clinical supply chains, including release and certification of investigational medicinal products used in worldwide trials.

You will ensure GMP/GDP compliance, support CAPA investigations, and act as a QA expert during Health Authority inspections and audits.