Associate Director, Therapeutic Area Quality Lead
Multiple Locations: United States • Raleigh, North Carolina, United States
Requisition Number: 5069
Position Title: Associate Director, Therapeutic Area Quality Lead
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 almost 2,500 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 the Associate Director, Therapeutic Area Quality Lead does at Worldwide
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.
What you will do
- Provide consultancy and oversight for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans.
- Maintain up to date electronic filing and management for QI and CAPA related documentation.
- Act as GCP Subject Matter Expert (SME), providing GCP consultancy to project teams within the assigned Therapeutic Area (TA) and for assigned functional area(s).
- Provide QA-to-QA relationship with Sponsor QA counterparts within the TA, including management of Quality Agreements and quality metrics.
What you will bring to the role
- Competency to manage projects/teams of significant scope and complexity with enthusiasm, prioritizing workload with attention to detail while meeting all deliverables and timelines.
- Ability to Communicate professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing.
- Demonstrate ability to successfully plan, adjust, manage, and optimize all resources for the advancement of QA goals and objectives.
- Customer focused approach to work.
- Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science and 7+ years of relevant GCP, GLP, GVP experience.
- Excellent working knowledge of, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
- Excellent understanding of drug development processes.
- Experience in supporting Regulatory Inspections.
- GPVP, GPP and GMP knowledge.
- IT literate, experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.
- M.S. or equivalent in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP and GPP experience.
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.
Employment Type: Regular
Community / Marketing Title: Associate Director, Therapeutic Area Quality Lead
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.
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.