Operations Manager Compliance - Parenteral Production

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Job Function:
Supply Chain Manufacturing

Job Sub Function:
Manufacturing Pharmaceutical Process Operations

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

Janssen Pharmaceutica is looking for a Compliance Manager - Aseptic Operations for the Innovative Medicine Supply Chain (IMSC) site in Beerse.

At Johnson & Johnson, we combine science, innovation, and the values of Our Credo to improve patient outcomes.

Together with more than 5,000 colleagues in Belgium, we work to deliver high-quality medicines safely and reliably.

The IMSC Beerse Operations department manufactures sterile drug products through a safe, compliant, and reliable supply chain.

Patient safety, contamination prevention, robust process control, and continuous improvement are central to our aseptic operations.

Job Summary:

The Compliance Manager - Aseptic Operations provides quality and compliance leadership within Production and oversees aseptic manufacturing activities.

Working across Operations, Quality, MSAT, Engineering, Environmental Monitoring, and other site functions, the role maintains a state of control and inspection readiness.

The Compliance Manager translates EU GMP requirements, including Annex 1, into practical manufacturing standards, supports the Contamination Control Strategy, identifies compliance risks and trends, and provides independent challenge or escalation when product quality or patient safety may be affected.

Your responsibilities will include:


* Provide day-to-day compliance oversight of aseptic manufacturing, including preparation, compounding, filling, interventions, and line clearance.


* Implement process improvements in the aseptic processing department.

Lead implementation of these enhancements.


* Ensure operational practices comply with EU GMP Annex 1, site procedures, registered requirements, and the Pharmaceutical Quality System.


* Support implementation, periodic review, and continuous improvement of the Contamination Control Strategy.


* Review and challenge aseptic practices, operator behaviours, cleanroom controls, material and personnel flows, interventi...