Aseptic Operations Compliance Lead

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking a Compliance Manager – Aseptic Operations at the IMSC Beerse site. You will provide quality and compliance leadership across production, quality, MSAT, engineering, and environmental monitoring to ensure a state of control and inspection readiness.

Responsibilities include oversight of aseptic manufacturing, implementation of process improvements, handling deviations, CAPAs, change controls, and maintaining readiness for regulatory inspections, while coaching teams

Qualifications

• Bachelor's degree 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.

Responsabilités

• 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.

Connaissances

Agile Manufacturing

BI

Quality Assurance

GMP

Process Improvement

Formation

Bachelor's degree in Pharmacy/Pharmaceutical Sciences/Engineering

Master's degree preferred

Description du poste

Johnson & Johnson is seeking a Compliance Manager – Aseptic Operations at the IMSC Beerse site. You will provide quality and compliance leadership across production, quality, MSAT, engineering, and environmental monitoring to ensure a state of control and inspection readiness.

Responsibilities include oversight of aseptic manufacturing, implementation of process improvements, handling deviations, CAPAs, change controls, and maintaining readiness for regulatory inspections, while coaching teams