Digital Quality Consultant

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

Line of Service

Advisory

Industry/Sector

Not Applicable

Specialism

Advisory - Other

Management Level

Manager

Job Description & Summary

About PwC

At PwC, our purpose is to build trust in society and solve important problems. We work with leading organisations to create meaningful impact, combining deep industry expertise , technology and human insight. In Belgium, we foster an inclusive, respectful and growth-oriented culture where people are encouraged to learn continuously, take ownership and collaborate across borders and disciplines. You will join a fast-paced and high-impact environment where your work contributes directly to better healthcare outcomes for patients and society.

About the Health Industries, Quality team

Our Health Industries, Quality team supports pharmaceutical, biotech and life sciences organisations in strengthening and transforming their quality operations across the end-to-end value chain. We help clients design, implement and optimise fit-for-purpose Quality Management Systems, operating at the intersection of regulation, strategy, operations and digital innovation.

What your day will look like

As a Quality Management Professional, you will take an active role in client engagements, working autonomously on well-defined workstreams while collaborating closely with colleagues and clients across Europe and beyond. Your day-to-day activities will include:

• Designing, implementi n g , 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.

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 .
• Master's degree in Engineering , Pharmaceutical Sciences, a Scientific Degree, or a related discipline.
• Strong working knowledge of GxP regulations (GMP, GDP, GCP as relevant) and a solid understanding of how digital systems support and evidence compliance.
• Experience in at least one of the following areas: eQMS implementation or migration, quality process design and automation, digital validation (CSA/CSV), quality data and analytics, or AI/ML applied to quality use cases .
• Experience gathering business requirements and working with IT, vendors and system integrators in a regulated environment is a strong plus .
• Background in consulting or advisory engagements is a plus.

Digital & AI Skills (Required Profile)

• High affinity for digital and AI , with genuine curiosity and drive to apply these technologies to quality challenges.
• Basic AI skills : practical experience using GenAI tools (e.g., ChatGPT, Copilot, Claude) for productivity, prompt engineering fundamentals, and understanding of core AI/ML concepts (LLMs, classification, anomaly detection) and their applicability to quality use cases.
• Good understanding of digital quality concepts : eQMS platforms, digital validation (CSA/CSV), data integrity (ALCOA+), process mining, quality analytics dashboards, RPA in quality, and AI governance / GxP considerations