Operations Manager Compliance - Parenteral Production

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Job Description:

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.

Job Summary:

The Compliance Manager – Aseptic Operations provides quality and compliance leadership within Production and oversees aseptic manufacturing activities. Working across Operations, Quality, MSAT, Engineering, Environmental Monitoring, and other site functions, the role maintains a state of control and inspection readiness. The Compliance Manager translates EU GMP requirements, including Annex 1, into practical manufacturing standards, supports the Contamination Control Strategy, identifies compliance risks and trends, and provides independent challenge or escalation when product quality or patient safety may be affected.

Your responsibilities will include:

• 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.

Leadership and general expectations:

• 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.

Qualifications:

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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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.