Head Of Quality Insights

Job description

Make your mark for patients To strengthen our Quality Management & Strategy we are looking for a talented profile to fill the position of: Head of Quality Insights – Braine l’Alleud, Belgium About the role Reporting to the Quality Management & Strategy Head, the Head of Quality Insights is accountable for generating enterprise-wide quality intelligence and providing leadership with a clear, data-driven view of quality performance, state of control, emerging Quality risks, inspection readiness and decision needs. The mission of the role is to own the Enterprise Management Review framework and ensure that information from across the quality ecosystem is consolidated, interpreted and transformed into meaningful insights, risk signals, executive readouts and decision-support materials. This role is the enterprise visibility and intelligence capability for Quality, enabling leadership to understand how the quality system and quality processes are performing, where risks are emerging, and where governance decisions or improvement actions are needed. You will work with You will work closely with the Quality Management & Strategy Head and the Quality Leadership Team, as well as a broad network of stakeholders across Quality Operations, Quality Management Systems (QMS), Quality Process Owners, Regulatory Intelligence, Audit and Inspection teams, and operational Quality teams. You will also collaborate with data owners, digital teams, process owners and other business partners to gather and interpret quality metrics, improve data quality, develop dashboards and scorecards, and identify emerging risks and performance trends. A key part of the role will be connecting these different stakeholders and ensuring leadership receives clear, reliable insights to support Quality governance and decision-making across the organization. What you will do Enterprise Management Review Ownership Define, maintain and continuously improve the enterprise Management Review framework, including scope, cadence, input requirements, review structure, data model, issue escalation logic and output expectations. Own the Management Review preparation process and ensure the right insights, risk signals, performance trends and decision topics are brought to leadership at the right level. Coordinate Management Review inputs from Quality Operations, Process Owners, QMS, Regulatory Intelligence, Audit/Inspection teams and other relevant stakeholders. Transform fragmented quality information into coherent, leadership-ready Management Review materials that enable meaningful discussion and decision-making. Quality Performance Framework and KPI Management Define and maintain the enterprise quality performance framework, including leading and lagging indicators, KPI definitions, reporting frequency, data ownership and interpretation rules. Create and maintain the enterprise Quality KPI catalogue, ensuring metrics are meaningful, risk-based, comparable and aligned with quality strategy and Management Review needs. Develop and maintain executive quality dashboards, scorecards and performance reports that provide clear visibility on quality performance and emerging concerns. Partner with data owners and process owners to improve metric definitions, data quality, reporting consistency and interpretation of performance signals. Quality Analytics Build and operate the enterprise quality insights capability, converting quality data into actionable insight, trend analysis and predictive signals. Analyze cross-system data from sources such as audits, inspections, deviations, CAPA, change control, complaints, training, document management, regulatory intelligence and operational quality processes where available. Produce quality insights reports that explain what the data means, why it matters and what decision or action may be needed. Regulatory Intelligence Integration Define and maintain the connection between Regulatory Intelligence outputs and enterprise Quality Intelligence, ensuring relevant regulatory trends, requirements and external signals are translated into quality implications. Integrate regulatory intelligence signals into Management Review inputs, quality risk discussions, inspection readiness assessments and executive quality reporting where relevant. Partner with Regulatory Intelligence process owners, topic leads and subdomain leads to ensure emerging regulatory expectations are assessed for potential QMS, process, documentation, training or compliance impact. Support leadership with clear interpretation of regulatory intelligence trends, highlighting potential risks, opportunities, prioritization needs and decisions required for the Quality organization Enterprise Quality Risk Define and maintain the enterprise quality risk intelligence approach, including risk heat maps, risk indicators, risk trend reporting and escalation signals. Provide risk inputs to Management Review, QMS Governance forums and quality leadership discussions. Ensure the role provides risk intelligence and escalation inputs without taking over ownership of risk treatment actions from process or operational owners. Inspection Readiness and State-of-Control Insights Provide enterprise-level inspection readiness insights by consolidating relevant signals from audits, inspections, commitments, CAPAs, recurring findings, process performance, training, standards implementation and quality risk trends. Identify areas where quality performance or risk indicators suggest potential inspection vulnerability or weakening state of control. Support leadership with evidence-based readiness readouts and clear visibility of unresolved quality risks and systemic themes. Executive Reporting, Decision Support and Continuous Improvement Prepare executive quality reporting that is concise, insight-driven, risk-based and focused on decisions, priorities and actions. Translate complex quality performance data into clear narratives, visual dashboards, risk heat maps and leadership readouts. Define data quality expectations for quality performance reporting, including ownership, definitions, timeliness, completeness, consistency and interpretation rules. Balanced Scorecard for Global Quality Prepare a ‘fit for purpose’ balanced scorecard for the overall global quality organization, bringing broader business performance indicators together regarding learning & growth, Quality’s business processes, customer satisfaction and the financials… allowing the Quality leadership team to make decisions on actions to improve the overall departmental performance. Work with the different business partners to define and gather the relevant metrics to bring them on a regular basis to the Quality Leadership Interested? For this position you’ll need the following education, experience and skills Bachelor’s, master’s degree or an education in a relevant scientific discipline Significant experience in pharmaceutical quality systems, Quality Management Review, quality performance management, quality risk management, analytics, audit/inspection readiness, quality operations or enterprise quality transformation. Fluent English communication (oral and written); any additional languages are a plus. Strong understanding of ICH Q10 principles, Management Review expectations, GxP quality systems, quality metrics, quality risk management, CAPA/deviation/change/audit processes, data governance, dashboards and inspection readiness. Ability to translate complex quality data into executive insight, influence stakeholders, challenge weak signals, drive accountability through evidence and build alignment across quality, digital, process and operational teams. Analytical, risk-based, transparent, rigorous, pragmatic, curious and system-oriented mindset, with a focus on proactive quality management and sustainable compliance. Strong capability to prepare concise executive readouts, dashboards, scorecards and decision-support materials. Ability to work across functions and trans