Senior Consultant Quality Management / Life Sciences (m/w/d)
Core
Develop innovative regulatory and compliance solutions for Life Sciences clients, focusing on Quality Management, process optimization, and IT system implementation.
Role type
Senior Consultant, Regulatory & Compliance Advisory
Builds
Smart solutions to navigate regulatory complexity for Life Sciences clients
Domain
Life Sciences / Regulatory Compliance / Quality Management
Required skills
Quality Management systems, Process optimization, Regulatory standards (ISO 13485, ISO 9001, EU GMP, 21 CFR Part 11), IT system implementation (eQMS), Audit planning and execution, Change management, Text mining, Quality by Design
Preferred skills
Project leadership in regulated processes, Experience in Life Science startups
Technologies
eQMS, Text Mining, AR
Responsibilities
Analyze and optimize Quality Management systems and organizational structures, Implement validated IT systems, Plan and conduct audits, Develop training programs, Contribute to strategy development and project management
Seniority
Senior, hands-on IC