Senior Qualified Person, Clinical Supply Quality

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Service anniversary

Insurance plans

Résumé du poste

Janssen Pharmaceutica NV in Beerse, Belgium, part of Johnson & Johnson, seeks a Delegate Qualified Person Clinical Supply Quality to strengthen Product Quality Management for clinical supply. You will lead batch release and QP certification for worldwide clinical trials, ensuring patient safety and compliance.

The role requires a university degree (Industrial Pharmacist) EU-certified Qualified Person and at least 3 years in pharmaceutical supply chain or QA.

Qualifications

• University degree in pharmacy (EU Qualified Person)
• At least 3 years of experience in pharmaceutical QA or supply chain
• Experience with 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 release and QA certification.
• Ensure GMP/GDP compliance, regulatory alignment and patient safety in trials.
• Provide coaching and training to operational teams on QA processes.
• Support audits/inspections and participate in quality review meetings.
• Lead CAPA investigations and ensure timely corrective actions.

Connaissances

Quality Assurance

Clinical Supply

Release management

cGMP knowledge

Regulatory inspections

Quality systems

Stakeholder management

Documentation

Formation

Industrial Pharmacist – EU certified Qualified Person

Description du poste

Janssen Pharmaceutica NV in Beerse, Belgium, part of Johnson & Johnson, seeks a Delegate Qualified Person Clinical Supply Quality to strengthen Product Quality Management for clinical supply. You will lead batch release and QP certification for worldwide clinical trials, ensuring patient safety and compliance.

The role requires a university degree (Industrial Pharmacist) EU-certified Qualified Person and at least 3 years in pharmaceutical supply chain or QA.