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
Builds
Fit-for-purpose Quality Management Systems, quality processes, and digital quality solutions for life sciences organizations.
Domain
Life Sciences / Pharmaceutical Quality Management / Regulatory Compliance
Deliverable
client delivery
Required skills
GDP compliance, QMS design and implementation, affiliate/local market quality oversight, distribution and warehousing quality, GxP regulations, Responsible Person (RP) activities, digital quality concepts (eQMS, validation, data integrity), AI and advanced analytics application to quality operations.
Preferred skills
Responsible Person (RP) qualification, Qualified Person (QP) certification, hands-on experience as RP/Deputy RP/QP, digital/AI domain certifications.
Technologies
eQMS platforms, GenAI tools (ChatGPT, Copilot, Claude), process mining, RPA, IoT-based cold-chain monitoring, serialization tools.
Responsibilities
Design and improve QMS and end-to-end quality processes (deviations, CAPA, change control, audits); Support quality engagements for GDP compliance and affiliate oversight; Advise on GDP-compliant distribution and cold-chain logistics; Apply AI and analytics to deviation triage, CAPA effectiveness, and audit readiness; Translate quality requirements into technology needs; Contribute to proposals and client-ready deliverables.
Seniority
Senior Associate, hands-on IC with advisory focus