DirecciónRequisition Number7604Employment Type : Regular
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 over 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 Management Associate does at Worldwide
The Quality Management Associate (QMA) is an essential role within the Quality Management Oversight (QMO) department responsible for and supporting GCP focused QA activities for clinical trials ensuring quality support across Therapeutic Areas.
What you will do
- Act as GCP Subject Matter Expert, providing GCP consultancy to project teams across Therapeutic Areas and for assigned functional area(s).
- Support the oversight of the management of quality issue investigations, root cause analysis and corrective / preventive actions.
- Collaborate and support the Therapeutic Area Quality Leads within the QMO team with QA activities assigned.
- May represent Quality Management Oversight department in Sponsor audits.
What you will bring to the role
- GCP focused experience to provide support to the oversight of the management of issues supporting projects / teams with enthusiasm and keen attention to detail to meet deliverables and timelines.
- Professional, concise, clear, and consistent communication and approach for internal and external customers.
- Clinical trial international or local regulation and guidance experience.
Your experience
- Bachelor’s degree with concentration in biological, physical, health, pharmacy or other related science and 2+ years of relevant GCP experience.
- Working knowledge of, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP.
- Understanding of drug development processes.
- Experience with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.
