Senior Specialist - R&D Quality
Core
Provide strategic quality oversight and compliance leadership across R&D Analytical, Microbiology, Stability, and Product Development functions to ensure adherence to QMS, GLP, GDP, and data integrity principles.
Role type
Senior Specialist, R&D Quality (Regulatory Compliance & Laboratory Oversight)
Builds
Self Care and Food product portfolios
Domain
Consumer Health / Personal Care / Food Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) expertise, Investigation & CAPA management, Supplier Quality Management, Audit Management (Lead Auditor), Data Integrity, Regulatory Compliance (GLP/GDP/GMP), Computer System Validation (CSV), Stability Program Oversight, Analytical Quality Review, Microbiology Laboratory Compliance
Preferred skills
Experience with Veeva Vault, Electronic Learning Management Systems (ELM), USFDA/EUGMP/WHO regulatory audit experience
Technologies
Veeva Vault, Electronic Learning Management Systems (ELM), Computerized Laboratory Systems
Responsibilities
Lead end-to-end management of laboratory investigations, deviations, and quality events; Provide quality oversight for stability programs supporting Self Care and Food product portfolios; Lead Auditor for supplier qualification, monitoring, and audit programs; Serve as a key quality representative during internal audits, external audits, and regulatory inspections; Drive laboratory compliance through routine assessments, laboratory rounds, and Gemba Walks; Provide quality review for Method Validation reports, Test Method reviews, and analytical protocols; Support validation and lifecycle management of computerized laboratory and quality systems.
Seniority
Senior, hands-on IC