Quality Management Systems Senior Specialist - Europe (Remote)
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AI Summary
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
Management of Planned and unplanned Quality Management Document deviations in accordance with WW procedures.
Receives departmental objectives, actively participating in determination of unit goals and strategies for meeting those goals and is measured on achievement of agreed objectives.
Support stakeholder training related to Quality Management system tools and Procedures as needed.
Develops and delivers training content pertaining to tools and procedures related to Quality Management Procedures.
Supervises maintenance of QMS trackers, tools and electronic systems as applicable.
Supports the process for external dissemination of Worldwide’s Quality Management records.
Conducts quarterly trends of Planned and unplanned deviations in accordance with WW QA procedures.
Reports trends and KPIs related to QMD planned and unplanned deviations to appropriate Governance Committee as applicable.
What you will bring to the role
Communicates professionally, effectively, clearly and consistently, both verbally and in writing.
Demonstrates a collaborative, customer-focused approach, leveraging opportunities to improve internal customer experiences.
Demonstrates critical thinking skills and ability to appropriately triage requests and concerns and escalate them.
Demonstrates a detail-oriented work style, driving departmental projects to closure.
Manages workload priorities and keeps management informed of challenges and potential solutions.
Experience with electronic Quality Management Systems (eQMS) an asset.
Your experience
Bachelor’s degree or 4-year degree equivalent in a scientific discipline.
Minimum of 3 years of experience working in clinical operations /monitoring or equivalent.
Experience in supporting noncompliance and Quality Issues and CAPAs within the last 2 years.
Previous experience in working as an end user or equivalent in a QMS Process.
Awareness of domestic and international GxP regulatory requirements.
Strong Microsoft Office skills, including in Excel, Word, Outlook, PowerPoint and SharePoint.
Audit or inspection support experience preferred.
Exceptional level of written and oral fluency in the English language.
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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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