Quality Compliance Management Specialist

Quality Compliance Management Specialist 📍 Walloon Brabant, Belgium About Nalys Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description
As a Quality Compliance Management Specialist, you will join the Quality Compliance team of a leading biopharmaceutical company. Working alongside the Head of Compliance Management, you will drive the department's performance monitoring, covering complaint governance, CMO oversight, KPI reporting and budget planning. This role sits at the crossroads of quality, data and coordination. You will turn operational data into clear performance indicators and identify trends and root causes. You will also make sure decision-makers have the right information ahead of key governance meetings. In addition, you will contribute to continuous improvement initiatives, including SOP compliance and the rollout of a new electronic Quality Management System (eQMS). We're looking for a structured, data-savvy quality professional who enjoys bringing clarity and rhythm to complex compliance processes. The Role & Responsibilities Reporting to the Head of Compliance Management and working closely with Quality, Operations and external partners, your responsibilities will include:
• Preparing, facilitating and following up the complaint forum, including action tracking
• Designing, generating and analysing KPIs to monitor the performance of contract manufacturing organisations (CMOs)
• Producing performance metrics and publishing them ahead of monthly quality forums
• Delivering weekly and monthly tracking reports on complaints and escalation activities
• Analysing data and trends to identify root causes and drive improvement actions
• Organising ad hoc meetings to address complex or sensitive complaints
• Building and maintaining the FTE budget template for the Quality Compliance department
• Supporting SOP compliance management and other improvement initiatives
• Contributing to the implementation of a new eQMS. Skills & Qualifications
• You hold a bachelor's or master's degree in sciences, pharmacy, engineering or a related field
• You have minimum 3 years' experience in quality or compliance within a GMP-regulated environment
• You are familiar with complaint handling, CAPA processes and CMO oversight
• You have strong analytical skills and are confident building KPIs and reports (advanced Excel; Power BI is a plus)
• You have exposure to eQMS tools (e.g., Veeva, TrackWise) or have taken part in a system implementation
• You are highly organised and comfortable driving meetings and following up actions with multiple stakeholders
• Your communication is clear and effective in English; French is an asset. Your Team You will be part of the Quality Compliance Management team, which makes sure that quality performance across internal and external operations is measured, monitored and continuously improved. The team works closely with Quality Assurance, Operations, Supply and external manufacturing partners to support compliance and operational excellence. The Recruitment Process By applying for the "Quality Compliance Management Specialist" position, you will go through the following steps in our recruitment process:
• Olivia Braszko, TA Specialist, will analyze your resume and schedule a first screening to answer your questions and assess your motivation
• You will have a second interview with our Technical Referent
• The last interview will be with our Business Unit Director, Jimmy Rousseaux. If you're passionate about turning quality data into meaningful improvements and want to be part of a forward-thinking team, we'd love to hear from you