Aseptic Operations Compliance Leader

Johnson & Johnson Innovative Medicine; Beerse; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine is seeking a Compliance Manager – Aseptic Operations for the Innovative Medicine Supply Chain (IMSC) Beerse site. Lead quality and compliance across aseptic manufacturing, translating EU GMP Annex 1 requirements into practical controls to ensure patient safety and regulatory readiness.

The role collaborates across Operations, Quality, MSAT, Engineering, and Environmental Monitoring, driving continuous improvement and CAPA effectiveness while maintaining

Qualifications

• Bachelor's degree in a relevant scientific field.
• At least five years of experience in pharmaceutical manufacturing, quality, or compliance within a GMP-regulated environment.
• 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.

Responsibilities

• Provide day-to-day compliance oversight of aseptic manufacturing.
• Implement process improvements in the aseptic processing department.
• 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.

Skills

Aseptic manufacturing

EU GMP Annex 1

CAPA

Root-cause analysis

Deviation management

Quality systems

Data integrity

Regulatory inspections

English proficiency

Education

Bachelor's degree

Master's preferred

Job description

Johnson & Johnson Innovative Medicine is seeking a Compliance Manager – Aseptic Operations for the Innovative Medicine Supply Chain (IMSC) Beerse site. Lead quality and compliance across aseptic manufacturing, translating EU GMP Annex 1 requirements into practical controls to ensure patient safety and regulatory readiness.

The role collaborates across Operations, Quality, MSAT, Engineering, and Environmental Monitoring, driving continuous improvement and CAPA effectiveness while maintaining