Quality Coordinator, Quality Management Systems - UK - Homebased

at  Worldwide Clinical Trials

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 3,500+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

YOUR EXPERIENCE

• Bachelor’s degree in a scientific discipline
• Minimum of two years of pharmaceutical, biotech or CRO experience with experience in supporting noncompliance and quality issues and CAPAs
• Experience working in and or with Quality Assurance and GxP activities preferred
• Awareness of domestic and international GxP regulatory requirements,
• Awareness of ICH GCP
• Strong Microsoft Office skills, including in Excel, Word, Outlook, PowerPoint and SharePoint

WHAT YOU WILL DO

Tasks may include but are not limited to:

• Supporting Non-compliance, Issue, Deviation and CAPA Management
• Conducts triage for QMS reports and requests.
• Supports QMS management of Non-Compliance/ Quality Issues/ CAPA/Complaints/Change control activities as defined in the procedures.
• Produce QMS metric trending and escalate risks to QMS leadership.
• Review and report QMS metrics as agreed by QMS leadership and Quality.
• Provide metrics dashboards for governance committees.
• Develop and conduct appropriate QC checks for Data being shared to ensure accuracy.
• Track and follow up with QMS operational internal stakeholders to ensure compliance with QMS actions and escalate delays /aging of actions

WHAT YOU WILL BRING TO THE ROLE

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• Champions Worldwide’s QMS by participating in and encouraging a strong quality culture.

• Manages workload priorities and keeps management informed of challenges and potential solutions.
• Works with a sense of urgency, recognizing and delivering time-sensitive deliverables by deadlines.
• Experience with electronic Quality Management Systems (eQMS) preferred.