Clinical Qa Manager Jobs

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.

Aurinia’s Working Environment Enables Every Individual To Thrive In a Professional Atmosphere Guided By Our Culture Values

Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization.

• Achieve together
• Collaborate
• Act responsibly
• Explore & build

Together, we drive to change the trajectory of autoimmune disease for patients in need.

Overview

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.

Responsibilities

• Directs Serious Breach related processes and reporting
• Supports departmental GxP related activities and projects
• Supports the assembly, maintenance, and archiving of study TMFs and their systems
• Contributes to the development and approval of QA and GCP related procedures (SOPs).
• Advises stakeholders on GCP Compliance issues and questions
• 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
• Participates in, and leads, as assigned, ongoing Inspections Readiness efforts and inspections
• Manages external auditors for contracted audits (contracts and audit specific activities)
• Works in partnership with related GxP functions operating within an aligned QMS while maintaining compliance with GMP requirements as appropriate
• Manages study and GCP related Deviations, Quality Issues, CAPA, and Root Cause Analysis
• Prepares KPIs for performance monitoring and Management
• Assists in providing GxP training to Aurinia
• Performs study audits as per audit plan and study needs (sites, systems, vendors, documents, )
• Ensures continued qualifications of GCP related vendors and systemsPrepares and negotiates QA Agreements with vendors, as applicable
• Contributes to QA Audit Planning

Requirements

• Functional knowledge of GMP requirements, especially IMP GMP
• Minimum of 3-5 years of relevant technical experience in the pharmaceutical industry
• Bachelor’s degree, preferably in health-related sciences
• 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
• Ability to deliver clear, effective communication orally and in writing (in English)
• Thorough knowledge of US and International GCP related regulations
• Strong working knowledge of Microsoft applications
• Thorough knowledge of ICH Good Clinical Practices (GCP)
• 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
• Minimum 2 years in a supervisory/management role preferred
• Understanding of Computer System Validation / Assurance requirements (CSV/CSA)
• Ability to work independently as well as in a team environment
• Clinical Good Laboratory Practice (cGLP) and Good Pharmacovigilance Practice (GVP) knowledge, preferred

Additional Information

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