Clinical QA Manager
- Remote, Home Office, United States
- Department: Quality
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health. In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
We are looking for a Clinical QA Manager 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.
• Ensures QA oversight and GCP compliance of all study activities as QA Lead on assigned study teams, working in close collaboration with Aurinia Clinical Operations group and CRO teams
• Contributes to QA Audit Planning
• Performs study 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 their systems
• Ensures continued qualifications of GCP related vendors and systems
• Prepares and negotiates QA Agreements with vendors, as applicable
• Manages study and GCP related Deviations, Quality Issues, CAPA, 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 GMP requirements as appropriate
• Participates in, and leads, as assigned, ongoing Inspections Readiness efforts and inspections
• Advises stakeholders on GCP Compliance issues and questions
• Prepares KPIs for performance monitoring and Management Oversight.
• Contributes to the development and approval of QA and GCP related procedures (SOPs).
• Assists in providing GxP training to Aurinia staff.
• Supports departmental GxP related activities and projects
• Bachelor’s degree, preferably in health-related sciences
• Minimum of 3-5 years of relevant technical experience in the pharmaceutical industry
• Minimum 2 years in a supervisory/management role preferred
• Thorough knowledge of ICH Good Clinical Practices (GCP)
• Thorough knowledge of US and International GCP related regulations
• Functional knowledge of GMP requirements, especially IMP GMP
• Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
• Clinical Good Laboratory Practice (cGLP) and Good Pharmacovigilance Practice (GVP) knowledge, preferred
• 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
• 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.