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.

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