Digital Quality Consultant
Core
Design, implement, and optimize Quality Management Systems (QMS) and digital quality processes for pharmaceutical and biotech clients, leveraging AI and advanced analytics.
Role type
Manager-level Digital Quality Consultant (Advisory)
Builds
End-to-end quality processes, eQMS implementations, quality analytics dashboards, and AI-enabled quality solutions.
Domain
Life Sciences / Pharmaceutical Quality Management / Digital Transformation
Required skills
Pharmaceutical quality management, GxP regulations (GMP, GDP, GCP), eQMS platforms (Veeva Vault, TrackWise), digital validation (CSA/CSV), AI/ML concepts, quality analytics, stakeholder management
Preferred skills
Agile delivery methods, certifications in digital/AI domains, experience with distribution quality (track & trace, IoT cold-chain)
Technologies
Veeva Vault, TrackWise, GenAI tools (ChatGPT, Copilot), RPA, process mining
Responsibilities
Design and implement QMS and quality processes; lead eQMS selection and deployment; apply AI and analytics to quality operations; advise on digital validation and compliance; build quality analytics capabilities; support AI governance frameworks.
Seniority
Manager, hands-on IC with client engagement ownership