Digital Quality Consultant

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 for AI-enabled systems.

Familiarity with digital tools supporting distribution quality (track & trace, serialization, IoT-based cold-chain monitoring) is a plus.

Skills

Strong communication , facilitation, and stakeholder-management skills, including the ability to engage with global quality leaders and local affiliate teams.

Ability to write compelling proposals and support business development.

Willingness to travel occasionally for client engagements, including affiliate and distribution site visits.

Nice to Have

Experience with agile delivery methods and tools ( Scrum, SAFe , Jira) in regulated environments

Certifications in digital/AI domains (e.g., AI fundamentals, Microsoft/Google AI certifications, Veeva Vault certifications).

What we will expect from you

At PwC, Professionals are expected to combine strong technical foundations with ownership, collaboration and a continuous learning mindset. In this role, we expect you to:

Take ownership of your work, manage priorities effectively and deliver high-quality outputs that meet client expectations in a dynamic and challenging environment.

Apply your practical experience in pharmaceutical quality, GDP and affiliate quality to analyse client situations, identify risks and propose pragmatic, compliant solutions.

Act as a trusted team member in client-facing settings, communicating clearly and professionally with global quality leaders, local affiliate teams and operational stakeholders.

Demonstrate a strong affinity for digital and AI-enabled ways of working, actively exploring how technologies such as eQMS , quality analytics and GenAI can improve quality performance and efficiency.

Work collaboratively and inclusively within diverse project teams, contributing to a supportive team culture while also showing autonomy and ambition in your personal development.

Continuously develop your expertise by staying up to date with GDP regulatory developments, national variations and emerging digital and AI trends in quality management.

Contribute to the growth of the practice by supporting business development, knowledge sharing and thought leadership initiatives.

What you can expect from us

At PwC Belgium, we invest in your growth, wellbeing and long-term career. You can expect:

A collaborative and inclusive work environment where diversity, respect and equal opportunities are fundamental.

Continuous learning and development through structured training, on-the-job learning, coaching and exposure to a wide range of clients and projects.

Opportunities to develop both technical expertise in quality, GDP and digital transformation, and essential consulting skills such as stakeholder management and problem solving.

Flexible working arrangements that support a healthy work-life balance and recognise individual needs.

Competitive compensation and benefits in line with the Belgian market, including