Operations Manager Compliance - Parenteral Production

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Manufacturing

Job Sub Function

Manufacturing Pharmaceutical Process Operations

Job Category

Professional

All Job Posting Locations

Beerse, Antwerp, Belgium

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 and contamination-control principles and 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 communic