Associate Director/Director, Clinical Quality Assurance

Associate Director/Director, Clinical Quality Assurance

Company: Aurinia Pharmaceuticals Inc.

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.

Skills

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 Pharmacovigilance Practices (GVP)
• Thorough knowledge of US and International GCP/GLP/GVP related regulations
• Functional knowledge of GMP requirements, especially IMP GMP
• Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
• Ability to deliver clear, effective communication orally and in writing (in English)
• Ability to work independently as well as in a team environment
• Attentive to the details, able to recognize critical attributes, steps and functions
• Well-organized, able to switch priorities quickly, coordinate several tasks at once and make quick informed decisions
• Some travel required (10-20%)
• Strong working knowledge of Microsoft applications, Veeva experience is a plus
• 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.