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) and US and International GCP regulations
Knowledge of GMP requirements, specifically IMP requirements, preferred
Requirements:
Provide QA oversight and ensure GCP compliance for all study activities, collaborating with cross-functional teams.
Conduct study audits per the defined audit plan (sites, systems, vendors, documents) and manage related CAPA, deviations, quality issues, and root cause analysis.
Maintain and archive study Trial Master Files (TMF) and support qualification of GCP/GLP/GCLP vendors; implement inspection readiness and KPI reporting.
Contribute to the development and enhancement of QA and GCP-related procedures and SOPs, ensuring alignment with regulatory requirements within the Quality Management System.
Job description
Description
Our Mission: Changing the trajectory of autoimmune diseases.
Our Vision:Enabling patients to live their fullest life.
We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.
Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.
We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own quality, and we proactively integrate quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and “We Care” so that patients can take our drugs with confidence.
Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia’s working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:
Achieve together
Collaborate
Explore & build
Act responsibly
Together, we drive to change the trajectory of autoimmune disease for patients in need.
Position: Clinical Quality Lead - Contractor
Department: Quality Assurance
Location: Remote
This position will report to the Associate Director, Clinical Quality Assurance.
Overview 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.
Primary 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
Requirements:
Qualifications
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
Additional Information All candidate information will be kept confidential according to EEO guidelines.
