Clinical Quality Lead Contractor

Overview

We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We pursue a broader portfolio of innovative autoimmune disease therapies while driving adoption of our approved therapy, LUPKYNIS, for appropriate people with lupus nephritis. We provide high quality products that are safe and effective. Each of us at Aurinia owns quality and proactively integrates quality into everything we do.

Exceptional quality and regulatory compliance are essential to our business, and we care so that patients can take our drugs with confidence.

We are looking for a Clinical Quality Lead (Contractor) to join our Quality Assurance team to advocate for the continued improvement of quality standards and a quality culture across the organization.

Position: Clinical Quality Lead - Contractor

Department: Quality Assurance

Location: Remote

This position will report to the Associate Director, Clinical Quality Assurance.

• 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)

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

All candidate information will be kept confidential according to EEO guidelines.

About the company

Aurinia Pharmaceuticals Inc.