Quality Management Associate (GCP)
Multiple Locations: North Carolina, USA • Indiana, USA • Ohio, USA • Georgia, USA • South Carolina, USA • Kansas, USA • Oklahoma, USA • Pennsylvania, USA • Alabama, USA • Tennessee, USA • Arkansas, USA • Texas, USA • Florida, USA
Requisition Number: 7603
Position Title: Quality Management Associate
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 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 the Quality Assurance Department does at Worldwide
The QA department sets the bar high when it comes to quality. We are committed to exceeding the quality standards required by our sponsors, study participants, and regulatory authorities. The QA culture is based on an environment where staff are trained, energized, and empowered to deliver high-quality products to our employees and customers.
What the Management Associate does at Worldwide
The Quality Management Associate (QMA) is responsible for the oversight, delivery, maintenance, reporting, and follow-up of assigned QA activities.
What you will do
- Champions the adoption of the Quality Management System (QMS)
- Supports the oversight and management of project-specific Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Plans
- Maintains up-to-date electronic filing and management for QI and CAPA-related documentation
- Serves as GCP Subject Matter Expert (SME), providing GCP consultancy to project teams across Therapeutic Areas (TAs) and for assigned functional area(s)
- Provides consultancy and reviews project-specific Quality Management Documents (QMDs) deviations
- 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
What you bring to the role
- Work with the QA team to plan, conduct, and complete written reports for each audit assigned.
- Monitor the projects and audit status in assigned areas and provide QA Management with the current status upon request.
- Assists with corrective and preventive action plans (CAPAs) to ensure follow-up and implementation of corrections for internal and external audits.
- Oversee the maintenance of records for each audit.
- Ability to speak, read, and write English fluently
- Working knowledge of ICH Guidelines, FDA Code of Federal regulations, European Directives, and UK Statutory Instruments
- Understanding of the Drug Development Process
- IT literate, experience with Microsoft-based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint
- bachelor's degree or equivalent in biological, physical, health, pharmacy, or other related science and 2+ years of relevant GCP experience in a scientific or allied health field preferably within a Clinical Research Organization (CRO) or pharmaceutical company setting
- Domestic and international travel may be required (not exceeding 10%)
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: Quality Management Associate (GCP)
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.
Location_formattedLocationLong: North Carolina, US
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.