Operations Manager Compliance - Parenteral Production

jj; Beerse; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson's Innovative Medicine Supply Chain Beerse site seeks a Compliance Manager – Aseptic Operations to provide quality leadership across Production and manage aseptic manufacturing activities.

You will translate EU GMP Annex 1 into practical controls, support the Contamination Control Strategy, and drive risk-based improvements with cross-functional teams to ensure patient safety and product quality.

Qualifications

• Bachelor's degree or equivalent in a relevant scientific discipline; a Master's is preferred.
• At least five years of experience in pharmaceutical manufacturing, quality, or compliance within GMP environments.
• Direct sterile/aseptic operations experience is required.
• Experience with health-authority inspections or internal audits is preferred.

Responsibilities

• Provide day-to-day compliance oversight of aseptic manufacturing activities.
• Lead continuous improvements in aseptic processing.
• Ensure practices comply with EU GMP Annex 1 and Pharmaceutical Quality System.
• Support Contamination Control Strategy reviews and improvements.
• Review aseptic practices, cleanroom controls, and environmental monitoring.
• Input to changes in aseptic processing environments and CAPA investigations.
• Maintain inspection readiness and support health-authority inspections.
• Coach teams on Annex 1 expectations, aseptic technique, data integrity, and quality ownership.

Skills

Agile Manufacturing

Business Intelligence

Change Management

Chemistry

Manufacturing

Quality Assurance

CMA/CMC

Data integrity

Process Improvements

Operational Excellence

Quality Risk Management

Coaching/Mentoring

Regulatory Knowledge

Communication

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Engineering, or other relevant scientific discipline

Master's degree preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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, 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.

Required Skills:

Preferred Skills:

Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing, and Control (CMC), Consulting, Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Manufacturing Processes, Mentorship, Operational Excellence, Organizational Knowledge, Plant Operations, Process Improvements, Process Optimization, Technical Credibility

The anticipated base pay range for this position is:

€79,800.00 - €137,770.00

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.