Clinical Quality Lead Contractor

Aurinia Pharmaceuticals

2d•Remote

About The Position

We are looking for a Clinical Quality Lead (Contractor) to join our Quality Assurance team, who can provide broad advocacy for the continued improvement of quality standards and a quality culture across the organization.

Requirements

Bachelor’s Degree, preferably in health-related sciences
Minimum of 4-6 years relevant technical experience in the pharmaceutical industry, clinical research, and/or Good Clinical Practice
Thorough knowledge of ICH Good Clinical Practices (GCP)
Thorough knowledge of US and International GCP regulations
Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering, and executing with integrity in all work and interactions with employees at all levels of the organization, as well as with vendors and customers

Nice To Haves

Knowledge of GMP requirements, specifically IMP requirements, preferred
Experience working in Clinical Good Laboratory Practices (cGLP), preferred
Strong working knowledge of Microsoft applications

Responsibilities

Supports QA oversight and GCP compliance of all study activities; working in close collaboration with Aurinia cross-functional teams
Performs study audits as per the defined audit plan and study needs (sites, systems, vendors, documents, etc.)
Supports the development, maintenance, completion, and archiving of study Trial Master Files (TMF)
Supports study and GCP related deviations, quality issues, CAPA, and Root Cause Analysis processes
Supports and implements CAPA actions derived from audit findings
Supports the continued qualification of all GCP, GLP, GCLP vendors related to the clinical studies being performed
Supports and develops ongoing Inspection Readiness efforts
Prepares KPIs for performance monitoring and management oversight
Works in partnership with all GxP related functions while operating within the Quality Management System maintaining compliance with regulatory requirements
Contributes to the development and enhancement of QA and GCP related procedures and processes (SOPs