Associate Director, Therapeutic Area Quality Lead

Requisition Number: 5069

Position Title: Associate 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 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.

Your experience

• 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. 

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: Associate 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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CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.