Aseptic Operations Compliance Manager

Johnson Johnson; Beerse; Sur place; EUR 90 000 - 115 000; Plein temps

Résumé du poste

Johnson & Johnson Beerse site seeks a Compliance Manager - Aseptic Operations to lead quality and regulatory compliance for sterile manufacturing within the Innovative Medicine Supply Chain. The role interfaces with Operations, Quality, MSAT, Engineering, and Environmental Monitoring to uphold contamination control and patient safety.

The candidate translates EU GMP Annex 1 requirements into practical standards, oversees investigations into deviations and CAPAs, and maintains readiness for

Qualifications

• 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.
• Experience with health-authority inspections, internal audits, regulatory commitments, or inspection-readiness programs is strongly preferred.

Responsabilités

• Provide day-to-day compliance oversight of aseptic manufacturing, including preparation, compounding, filling, interventions, and line clearance.
• Lead process improvements in the aseptic processing department and drive implementation.
• Ensure practices comply with EU GMP Annex 1, site procedures, registered requirements, and the Pharmaceutical Quality System.
• Support Contamination Control Strategy improvements and periodic reviews.
• Lead investigations into deviations and contamination risks; ensure CAPAs are timely and effective.
• Maintain inspection readiness and support health-authority inspections and internal audits.

Connaissances

Aseptic manufacturing

EU GMP Annex 1

CAPA

Regulatory compliance

Quality risk management

Formation

Bachelor's degree in Pharmacy or related

Master's preferred

Description du poste

Johnson & Johnson Beerse site seeks a Compliance Manager - Aseptic Operations to lead quality and regulatory compliance for sterile manufacturing within the Innovative Medicine Supply Chain. The role interfaces with Operations, Quality, MSAT, Engineering, and Environmental Monitoring to uphold contamination control and patient safety.

The candidate translates EU GMP Annex 1 requirements into practical standards, oversees investigations into deviations and CAPAs, and maintains readiness for