Senior Associate Quality Management
Core
Design, implement, and optimize Quality Management Systems (QMS) for pharmaceutical and biotech clients, focusing on GDP compliance, distribution, warehousing, and digital quality initiatives.
Role type
Senior Associate Quality Management Consultant (Advisory)
Builds
Fit-for-purpose QMS, affiliate quality frameworks, and digital quality solutions for pharma/biotech clients.
Domain
Life Sciences / Pharmaceutical Quality Management / Regulatory Compliance
Deliverable
client delivery
Required skills
GDP compliance, QMS design, affiliate quality oversight, distribution & warehousing quality, digital quality concepts, AI/ML fundamentals, stakeholder management
Preferred skills
Responsible Person (RP) qualification, QP certification, eQMS platform experience, AI governance knowledge
Technologies
eQMS platforms, GenAI tools, process mining, RPA, IoT cold-chain monitoring
Responsibilities
Design and improve QMS processes (deviations, CAPA, audits), support GDP-compliant distribution and warehousing operations, implement digital quality initiatives, apply AI/analytics to quality operations, translate quality requirements into technology needs.
Seniority
Senior Associate, hands-on IC with advisory responsibilities