Quality Management Associate
Multiple Locations: Morrisville, NC, USA • United States
Requisition Number: 5068
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 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 Quality Management Associates do 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
- Provide consultancy and oversight for project-specific 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/GLP/GcLP Subject Matter Expert (SME), provides GCP/GLP/GcLP consultancy to project teams.
- Provide consultancy and reviews project-specific Quality Management Documents (QMDs) deviations.
- Perform study data review and trending activities as assigned.
- Collaborate with Risk Based Quality Management to support ongoing risk assessment as assigned.
- May assist with Sponsor audits and regulatory inspections as assigned.
What you will bring to the role
- Ability to speak, read and write English fluently.
- Understanding of the Drug Development Process
- Critical thinking skills.
- Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
- College/University degree in nursing, biological, physical, health, pharmacy, or other related science.
- Working knowledge of ICH Guidelines, FDA regulations, European Directives, and MHRA Statutory Instruments.
- 2+ years of relevant GCP, GLP, GVP experience.
- IT Literate, experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.
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!
Employment Type: Regular
Community / Marketing Title: Quality Management Associate
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: Morrisville, North Carolina US
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.