Quality Management Systems Senior Specialist - Europe
Job Title: Quality Management Systems Senior Specialist - Europe (Remote)
Job Location: Virtual United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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 3,500+ 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.
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 Assurance Department does at Worldwide
The Quality Assurance 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. Our 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 you will do
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Management of Planned and unplanned Quality Management Document deviationsin accordance withWW procedures.
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Receives departmentalobjectives, activelyparticipatingin determination of unit goals and strategies for meeting those goals and is measured on achievement of agreedobjectives.
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Support stakeholder training related to Quality Management system tools and Procedures as needed.
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Develops and delivers training contentpertaining totools and procedures related to Quality Management Procedures.
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Supervises maintenance of QMS trackers,toolsand electronic systems as applicable.
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Supports the process for external dissemination ofWorldwide’sQuality Management records.
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Conducts quarterly trends of Planned and unplanned deviationsin accordance withWW QA procedures.
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Reports trends and KPIs related to QMD planned and unplanned deviations to appropriate Governance Committee as applicable.
What you will bring to the role
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Communicates professionally, effectively,clearlyand consistently, both verbally and in writing.
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Demonstrates a collaborative, customer-focused approach,leveragingopportunities to improve internal customer experiences.
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Demonstrates critical thinking skills and ability to appropriately triage requests and concerns and escalate them.
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Demonstrates a detail-oriented work style, driving departmental projects to closure.
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Manages workload priorities and keeps management informed of challenges and potential solutions.
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Experience with electronic Quality Management Systems (eQMS) an asset.
Your experience
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Bachelor’s degree or 4-year degree equivalent in a scientific discipline.
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Minimum of 3 years of experience working in clinical operations /monitoring or equivalent.
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Experience in supporting noncompliance and Quality Issues and CAPAs within the last 2 years.
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Previousexperience in working as an end user or equivalent in a QMS Process.
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Awareness of domestic and internationalGxPregulatory requirements.
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Strong Microsoft Office skills, including in Excel, Word, Outlook,PowerPointand SharePoint.
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Audit or inspection support experience prefe