Senior QA Lead, Clinical Supply Quality

jj; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Janssen Pharmaceutica NV, part of Johnson & Johnson, seeks a Senior QA Associate to strengthen the Product Quality Management - Clinical Supply Quality team. The role ensures quality oversight over clinical supply chains for diverse products, including small and large molecules and ATMPs, with focus on release and certification of IMPs for worldwide trials.

Key duties include QP certification collaboration, QA approvals of GMP documents, and handling deviations/inspections.

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.
• Experience with Quality Systems and regulatory inspections and preparedness (cGMP, ICH).

Responsabilités

• Perform batch release for clinical trial material within the IMP license scope.
• Represent QA Clinical Supply Chain in cross‑functional teams to secure timely release and QP certification.
• Ensure GMP and GDP compliance, support investigation and CAPA activities.
• Provide QA coaching and training to operational teams and participate in quality review meetings.
• Act as spokesperson during Health Authority inspections and customer audits.

Connaissances

Release management

Quality systems

Regulatory inspections

cGMP knowledge

ICH guidelines

Stakeholder management

QA coaching

Audit readiness

Formation

University degree, Industrial Pharmacist – EU Qualified Person

Description du poste

Janssen Pharmaceutica NV, part of Johnson & Johnson, seeks a Senior QA Associate to strengthen the Product Quality Management - Clinical Supply Quality team. The role ensures quality oversight over clinical supply chains for diverse products, including small and large molecules and ATMPs, with focus on release and certification of IMPs for worldwide trials.

Key duties include QP certification collaboration, QA approvals of GMP documents, and handling deviations/inspections.