Director, Therapeutic Area Quality Lead

Multiple Locations: North Carolina, United States • Massachusetts, United States • Pennsylvania, United States

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Requisition Number: 3305

Position Title: Director, Therapeutic Area Quality Lead

External Description:

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

Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not all-inclusive

Skills & Abilities:

· 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


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
· Bachelor’s degree with a 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%)





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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