Quality Assurance Group Leader
Core
Lead a Quality Assurance group to ensure regulatory compliant development and testing services under GLP and/or CGMP regulations.
Role type
Mid-level supervisory Quality Assurance Group Leader
Builds
Quality assurance programs and systems for analytical testing services
Domain
Life sciences / Pharmaceutical testing / GLP and CGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP and/or CGMP compliance, HPLC and/or GC knowledge, LIMS system usage, Empower review, laboratory setting experience, supervisory leadership, conflict resolution, CAPA management, audit coordination, protocol and SOP review
Preferred skills
Chemistry/Biochemistry/Biology/Chemical Engineering degree, cross-trained staff development, client and regulatory audit hosting
Technologies
LIMS, Empower, HPLC, GC
Responsibilities
Manage day-to-day QA activities and staff; mentor and train QA personnel; review staff work and controlled documents; formulate QA goals; interpret and communicate GLP/CGMP philosophy; develop and implement quality systems and metrics; schedule and host audits; decide on product acceptance or supplier engagement; drive investigations and CAPAs; review protocols, data, and reports for regulatory compliance; update master schedules; file quality documents.
Seniority
Mid-level, hands-on supervisor