Operations Manager Compliance - Parenteral Production

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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.

• →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, interventions, cleaning and disinfection, and environmental monitoring.
• →Provide compliance input to changes in the aseptic processing environment.
• →Lead or support investigations into deviations, sterility-assurance events, environmental monitoring excursions, contamination risks, and adverse trends; ensure CAPAs are timely, sustainable, and effective.
• →Maintain inspection readiness and represent or support Aseptic Operations during health-authority inspections, internal audits, and quality check rounds.
• →Coach teams on Annex 1 expectations, aseptic technique, contamination-control principles, data integrity, and quality ownership.

• Maintain a visible shop-floor presence and promote open reporting, learning, disciplined execution, and a strong quality culture.
• Build effective partnerships across Operations, Quality, Engineering, MSAT, and Environmental Monitoring.

Education and experience:

• Bachelor's degree or equivalent in Pharmacy, Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Engineering, or another relevant scientific discipline; a Master's degree is preferred.
• At least five years of experience in pharmaceutical manufacturing, Quality, or compliance within a GMP-regulated environment, including direct sterile or aseptic operations experience.
• Demonstrated experience overseeing aseptic manufacturing activities and resolving complex compliance issues cross-functionally.
• Experience with health-authority inspections, internal audits, regulatory commitments, or inspection-readiness programs is strongly preferred.

Experience and skills:

• In-depth knowledge of EU GMP Annex 1 and its practical application to sterile medicinal-product manufacture.
• Ability to interpret regulations and technical data, assess risk, and translate requirements into pragmatic manufacturing controls.
• Proficiency in deviation management, root-cause analysis, CAPA, change control, trending, and quality risk management.
• Strong influencing, coaching, facilitation, and communication skills across shop-floor, technical, and senior-leadership audiences.
• Fluent written and spoken English; Dutch is an advantage.

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