Quality Management Associate, GCP - EMEA - Homebased

Who We Are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
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.
  

We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
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.