Jobs and Careers

Associate Director/Director, Clinical Quality Assurance

United States, United Statesfull_timeVerifiedPosted 23 Jul 2025

About the role

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. Overview We are looking for an Associate Director/Director Clinical QA 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.Responsibilities:

Ensures QA oversight, GCP and GLP compliance of all study activities as QA Lead on assigned study teams, working in close collaboration with Aurinia Clinical Operations and CRO teams
Supports the implementation, execution, and performance oversight of the PV QMS and PV System for clinical and commercial operations, working in close collaboration with Aurinia Global Patient Safety
Contributes to QA Audit Planning
Performs GCP, GLP, and PV audits as per audit plan and study needs (sites, systems, vendors, documents, etc.)
Manages external auditors for contracted audits (contracts and audit specific activities)
Supports the assembly, maintenance, and archiving of study TMFs and systems
Ensures continued qualifications of GCP, GLP, and GVP related vendors and systems
Prepares and negotiates Quality Agreements with vendors, as applicable
Manages study, GCP, GLP, and GVP related Deviations, Quality Issues, CAPA, Effectiveness Checks and Root Cause Analysis
Directs Serious Breach related processes and reporting
Works in partnership with related GxP functions incl. operating within an aligned QMS while maintaining compliance with regulatory requirements
Participates in, and leads, as assigned, ongoing Inspections Readiness efforts and inspections (GCP, GLP, and GVP/PADE)
Advises stakeholders on GCP, GLP, and GVP Compliance issues and questions
Prepares KPIs for performance monitoring and Management Oversight.
Contributes to the development and approval of QA, GCP, GLP, and GVP related procedures (SOPs).
Assists in providing GxP training to Aurinia staff.
Supports departmental GxP related activities and projects
General:

Completes required Standard Operating Procedures (SOPs) training, as identified in training syllabus or job matrix.
Follows approved policies and procedures as written.
Attends all required training sessions and obtains a passing score.
Ensures that the department’s duties are carried out promptly, effectively, and efficiently.
Other Duties as identified/assigned by management

Qualifications:

Bachelor’s degree, preferably in health-related sciences
Minimum of 6-8 years of relevant technical experience in the pharmaceutical industry
Minimum 4 years in a supervisory/management role preferred
Thorough knowledge of ICH Good Clinical Practices, OECD Good Laboratory practices, and Good Pharmacovi