Operations Manager Compliance - Parenteral Production (Aseptic Operations)

Location: Beerse, Antwerp, Belgium

Salary: €79,800–€137,770 base pay annually

Company

Johnson & Johnson develops healthcare, Innovative Medicine, and MedTech solutions, including high-quality pharmaceutical products.

What you will do

• Provide daily compliance oversight for aseptic manufacturing, including preparation, compounding, filling, interventions, and line clearance.
• Translate EU GMP Annex 1, site procedures, registered requirements, and the Pharmaceutical Quality System into practical manufacturing standards.
• Support and continuously improve the Contamination Control Strategy, cleanroom controls, material and personnel flows, cleaning, disinfection, and environmental monitoring.
• Lead or support investigations into deviations, sterility-assurance events, environmental-monitoring excursions, contamination risks, and adverse trends.
• Ensure CAPAs are timely, sustainable, and effective, while maintaining inspection readiness for health-authority inspections, internal audits, and quality checks.
• Coach production teams on aseptic technique, contamination control, data integrity, and quality ownership, working with Quality, MSAT, Engineering, and Environmental Monitoring.

Requirements

• Bachelor’s degree or equivalent in Pharmacy, Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Engineering, or a related scientific discipline; a master’s degree is preferred.
• At least five years of experience in pharmaceutical manufacturing, Quality, or compliance in a GMP-regulated environment, including direct sterile or aseptic operations experience.
• Experience overseeing aseptic manufacturing and resolving complex compliance issues across functions.
• In-depth knowledge of EU GMP Annex 1 and its application to sterile medicinal-product manufacturing.
• Proficiency in deviation management, root-cause analysis, CAPA, change control, trending, and quality risk management.
• Fluent written and spoken English required; Dutch is an advantage.

Nice to have

• Master’s degree in a relevant scientific discipline.
• Experience with health-authority inspections, internal audits, regulatory commitments, or inspection-readiness programs.
• Dutch language skills.

Culture & Benefits

• Full-time position with a visible shop-floor presence and emphasis on open reporting, learning, disciplined execution, and quality culture.
• Cross-functional collaboration across Operations, Quality, Engineering, MSAT, and Environmental Monitoring.
• Annual bonus based on pay grade, location, and employee and company performance.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health, plus eligible insurance plans and recognition awards.