Digital Quality Consultant

About the role

Join PwC Belgium’s Health Industries Quality team to help pharmaceutical, biotech and life‑science clients transform their quality operations through digital innovation. You will work on high‑impact engagements, designing and implementing modern Quality Management Systems while applying AI and advanced analytics to improve outcomes.

Key responsibilities

• Design, implement, digitise and improve Quality Management Systems and end‑to‑end quality processes such as deviations, CAPA, change control, complaints, audits, supplier quality management and management review.
• Support and deliver digital quality management engagements for pharma and biotech clients, focusing on eQMS implementation, migration, process design, automation and digital validation.
• Lead eQMS selection and deployment activities (e.g., Veeva Vault, TrackWise) including requirement gathering, configuration workshops and validation.
• Apply AI and advanced analytics to quality operations, e.g., deviation triage, predictive quality, audit readiness, complaint trend analysis and automated document review.
• Advise clients on digital validation, data integrity (ALCOA+), electronic records and signatures (Annex 11 / 21 CFR Part 11) and GxP considerations for AI‑enabled systems.

Required profile

• Minimum 4 years of experience in pharmaceutical quality management, digital quality or related consulting roles.
• Master’s degree in Engineering, Pharmaceutical Sciences, a scientific discipline or a related field.
• Strong knowledge of GxP regulations (GMP, GDP, GCP) and how digital systems support compliance.
• Experience with eQMS implementation or migration, quality process automation, digital validation or quality analytics, preferably with AI/ML use cases.

Required skills

• eQMS platforms (e.g., Veeva Vault, TrackWise)
• Digital validation (CSA/CSV) and data‑integrity standards (ALCOA+)
• AI/ML concepts and generative AI tools (ChatGPT, Copilot, Claude)
• Quality analytics tools, process mining and KPI dashboards
• Stakeholder management and strong communication abilities

What we offer

• Collaborative and inclusive work environment with continuous learning opportunities.
• Flexible working arrangements supporting work‑life balance.
• Competitive compensation and benefits aligned with the Belgian market.
• Opportunities to work on impactful projects improving healthcare supply chains.