Digital Quality Consultant

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 industryexpertisetechnologyand human Belgium we foster an inclusiverespectfuland growth-oriented culture where people areencouraged 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 IndustriesQuality team supports pharmaceuticalbiotechand life sciences organisations in strengthening and transforming their quality operations across the end-to-end value chain. We help clients designimplementand optimise fit-for-purpose Quality Management Systemsoperatingat the intersection of regulation strategyoperationsand 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 implementingdigitizingand improving Quality Management Systems and end-to-end quality processes such as deviations CAPA change control complaints audits supplier qualitymanagementand management review.

• Supporting and deliveringdigitalquality management engagements for pharmaceutical and biotech clients with a focus oneQMSimplementation and migration quality process design and automation and/or digitalvalidation.

• Leading and supportingeQMSselectionand deployment activities(e.g. Veeva VaultTrackWise ) 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 trendanalysisand automated document review.

• Advising clients on digital validation and compliance including Computer Software Assurance (CSA/CSV) data integrity (ALCOA) electronicrecordsandsignatures (Annex 11 / 21 CFR Part 11) andGxPconsiderations for AI-enabled systems.

• Building quality analytics and performance management capabilities including KPI frameworks quality dashboards processminingand 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 auditreadinessand 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 qualityclarityand consistency.

Qualifications

• Minimum 4 years of experience in pharmaceutical quality managementdigital qualityquality consulting or related roles withdemonstrable exposureeQMSplatformsqualitydigitizationand/or quality analytics.

• Masters degree in Engineering Pharmaceutical Sciences a Scientific Degree or a related discipline.

• Strong working knowledge ofGxPregulations(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:eQMSimplementation or migration quality process design and automation digital validation (CSA/CSV) quality data and analytics or AI/ML applied to quality use cases.

• Experiencegathering 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:eQMSplatforms digital validation (CSA/CSV) data integrity (ALCOA) process mining quality analytics dashboards RPA in quality and AI governance /GxPconsiderations 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 withagiledelivery methods and tools (ScrumSAFe 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 ownershipcollaborationand a continuous learning 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 situationsidentifyrisksand propose pragmatic compliant solutions.

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

• Demonstrate a strong affinity for digital and AI-enabled ways of working actively exploring how technologies such aseQMS 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 yourexpertiseby staying up to date with GDP regulatory developments nationalvariationsand 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 growthwellbeingand 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 learningcoachingand exposure to a wide range of clients and projects.

• Opportunities to develop both technicalexpertisein 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 wellbeing initiatives and mobility options.

• The opportunity to work on meaningful projects that contribute to safer moreefficientand more resilient healthcare supply chains.

Final words about PwC

Joining PwC means becoming part of a global network of professionals who are passionate about making a difference. If you are motivated by quality innovation and purpose-driven work and you want to grow in a challenging yet supportive environment we would be delighted to hear from you. At PwC Belgium your ideas yourcuriosityand your ambition truly matter.