Senior Associate Quality Management
pwc · Brussels
Job description
About the role
PwC is looking for a Senior Associate to join its Health Industries Quality team in Brussels. You will work on high‑impact projects that help pharmaceutical, biotech and life‑science clients improve their quality management systems and deliver better healthcare outcomes.
Key responsibilities
- Design, implement, digitise and optimise Quality Management Systems (QMS) covering deviations, CAPA, change control, complaints, audits and supplier quality.
- Lead eQMS selection, configuration and validation projects using platforms such as Veeva Vault and TrackWise.
- Apply AI and advanced analytics to quality operations, including deviation triage, CAPA effectiveness, predictive quality and audit readiness.
- Advise on digital validation, 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.
- Build quality analytics, KPI frameworks, dashboards, process‑mining models and data‑integration solutions across the value chain.
- Support AI governance and responsible‑AI frameworks for regulated environments.
Required profile
- University degree in life sciences, engineering, pharmacy or a related field.
- Experience in quality management within pharma/biotech or consulting environments.
- Ability to work autonomously on defined workstreams and collaborate with cross‑border teams.
- Strong communication skills in English; French is a plus.
Required skills
- eQMS platforms: Veeva Vault, TrackWise
- AI and advanced analytics for quality operations
- Digital validation, CSA/CSV, ALCOA+
- Electronic records & signatures (Annex 11, 21 CFR Part 11)
- GxP compliance
- KPI development, quality dashboards, process mining, data modelling
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Published 1 maand geleden
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pwc
Brussels
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