AI-Driven Digital Quality Manager (Pharma)

PwC; Brussel; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

PwC Belgium’s Health Industries, Quality team helps pharmaceutical, biotech and life sciences organisations strengthen quality operations across the value chain. You will design and implement quality management systems, support eQMS deployment and apply AI-driven analytics to improve compliance and performance.

The role focuses on leading digital quality initiatives, regulatory alignment (GxP), and collaborating with cross-functional teams to deliver end-to-end quality solutions for European

Qualifications

• Minimum 4 years of experience in pharmaceutical quality management, digital quality, quality consulting, or related roles, with demonstrable exposure eQMS platforms, quality digitization and/or quality analytics.

Responsabilités

• Designing, implementing, digitizing and improving Quality Management Systems and end-to-end quality processes such as deviations, CAPA, change control, complaints, audits, supplier quality management and management review.
• Supporting and delivering digital quality management engagements for pharmaceutical and biotech clients, with a focus on eQMS implementation and migration, quality process design and automation and / or digital validation.
• Leading and supporting eQMS selection and deployment activities (e.g., Veeva Vault, TrackWise, ...) including requirement gathering, configuration workshops and validation.
• Applying AI and advanced analytics to quality operations - for example deviation triage and classification, CAPA effectiveness, predictive quality, audit readiness, complaint trend analysis and automated document review.
• Advising clients on digital validation and compliance, including Computer Software Assurance (CSA/CSV), data integrity (ALCOA+), electronic records and signatures (Annex 11 / 21 CFR Part 11) and GxP considerations for AI-enabled systems.
• Building quality analytics and performance management capabilities, including KPI frameworks, quality dashboards, process mining and data models that connect quality data across the value chain.
• Supporting AI governance and responsible-AI frameworks for regulated environments, covering model lifecycle management, human oversight, explainability and audit trails.
• Applying AI and advanced analytics concepts to quality operations, for example in deviation triage, CAPA effectiveness, predictive quality, audit readiness and complaint trend analysis.
• Working with cross-functional teams, including tax and technology colleagues, to deliver integrated and end-to-end solutions for clients.
• Translating quality process requirements into clear technology needs and supporting solution and vendor assessments.
• Contributing to proposals, statements of work and client-ready deliverables, ensuring high quality, clarity and consistency.

Description du poste

PwC Belgium’s Health Industries, Quality team helps pharmaceutical, biotech and life sciences organisations strengthen quality operations across the value chain. You will design and implement quality management systems, support eQMS deployment and apply AI-driven analytics to improve compliance and performance.

The role focuses on leading digital quality initiatives, regulatory alignment (GxP), and collaborating with cross-functional teams to deliver end-to-end quality solutions for European