Aurinia Pharmaceuticals Inc.
Associate Director/Director, Clinical Quality Assurance
Aurinia Pharmaceuticals Inc., Rockville, Maryland, us, 20849
Overview
Associate Director/Director, Clinical Quality Assurance
role at
Aurinia Pharmaceuticals Inc.
is to provide broad advocacy for the continued improvement of quality standards and a quality culture across the organization. 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 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.
We are a dedicated team of experts guided by our Culture Values: Achieve together, Collaborate, Explore & build, Act responsibly.
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 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.
Seniority level Director
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries Pharmaceutical Manufacturing
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role at
Aurinia Pharmaceuticals Inc.
is to provide broad advocacy for the continued improvement of quality standards and a quality culture across the organization. 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 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.
We are a dedicated team of experts guided by our Culture Values: Achieve together, Collaborate, Explore & build, Act responsibly.
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 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.
Seniority level Director
Employment type Full-time
Job function Research, Analyst, and Information Technology
Industries Pharmaceutical Manufacturing
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