Mgr (Qualified Person), Clinical Supply Chain Quality

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is looking for a manager to strengthen the Clinical Supply Quality (CSQ) team! We are a motivated team ensuring quality oversight over multiple and complex clinical supply chains for innovative products, including synthetics and biotherapeutics, and advanced therapies.

Our responsibilities include the certification and release of investigational medicinal products (IMPs) used in worldwide J&J sponsored clinical trials, ensuring patient safety and compliance with applicable regulations.

In this role, you will act as a Qualified Person (QP) delegate and Quality Point of Contact, contributing to end-to-end quality oversight across the clinical supply chain with the ultimate goal of providing hope in a box to our patients.

Are you interested in making a meaningful impact on patients' lives by ensuring the highest quality standards in innovative medicines? Then we would like to hear from you.

Key Responsibilities

As a manager, you will:


* Act as Qualified Person (QP) delegate, responsible for certification and release of investigational medicinal products in accordance with EU GMP Annex 16 and Clinical Trial Regulation requirements


* Grow into a back-up Qualified Person (QP) role over time


* Serve as Clinical Supply Chain Quality Point of Contact for assigned product portfolios, ensuring alignment of inputs required for timely QP release and certification


* Ensure compliant release of clinical trial materials by reviewing batch documentation, analytical results, and regulatory requirements across formulation, filling, packaging, testing, and storage activities


* Collaborate closely with Clinical Supply Chain (CSC) groups and global stakeholders (e.g.

ECSQ, PQM, External Supply) to enable a reliable and compliant supply chain


* Represent CSQ in cross-functional teams and ensure quality requirements are embedded from early clinical trial execution onwards


* Provide quality o...