Director, Therapeutic Area Quality Lead

Requisition Number: 4928

Position Title: Director, Therapeutic Area Quality Lead

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.  

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.  

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What you will do

SUMMARY: The Therapeutic Area Quality Lead (TAQL) is responsible for the oversight, delivery, maintenance, reporting, and follow up of QA activities for an assigned therapeutic area within the Quality Clinical Oversight Program to ensure the quality of deliverables within their purview.  

· Provides consultancy and oversight for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans
· Acts as GCP Subject Matter Expert (SME), providing GCP consultancy to project teams within the assigned Therapeutic Area (TA) and within the assigned GCP consultancy SME area
· Responsible for QA review of Quality Management Documents (QMDs) within GCP consultancy SME area during revisions or regular review cycles
· Provides GCP consultancy on, and reviews of, QMD deviations for project teams within the assigned TA and within the GCP consultancy SME area
· Provides inspection and audit support as required
· Responsible for the QA-to-QA relationship with Sponsor QA counterparts within the TA, including management of Quality Agreements and quality metrics
· Partners with Risk Based Quality Management to support ongoing risk assessment for projects within the TA
· Manages the business/operational relationship between QA and with the operational and TA leadership
· Responsible for oversight and mentoring of Quality Study Representative(s) assigned to the TA
· Maintains up to date electronic filing and management for QI and CAPA related documentation

What you will bring to the role 
· Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
· Customer focused approach to work
· Demonstrates excellent critical thinking skills
· Demonstrates the ability to successfully plan, adjust, manage, and optimize all resources for the advancement of QA goals and objectives
· Competent to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines
· Works independently, takes initiative and has a flexible approach to work assignments and other assigned tasks.
· Provides coaching, mentoring and constructive feedback to employees inclusive of peer performance evaluations and individual training programs, as assigned
· Adheres to Worldwide Travel Policy

Your experience 
· Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP
· Ability to speak, read and write English fluently
· Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA regulations, European Directives and Regulations, and MHRA Statutory Instruments relevant to GCP
· Excellent understanding of drug development processes
· Experience in supporting Regulatory Inspections is an asset, but not essential
· GPVP, GPP and GMP knowledge is an asset, but not essential
· IT literate, experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
· M.S. in a scientific or allied health field and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experience
OR
· Bachelor’s degree with concentration in biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP, GLP, GVP experience
· Domestic and international travel may be required (not exceeding 15%)

Why Worldwide  

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.    

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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Employment Type: Regular

Community / Marketing Title: Director, Therapeutic Area Quality Lead

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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