Senior Specialist, Quality Management Documentation – Europe

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

• Perform document control activities and ensure consistency and compliance with applicable standards for procedural document development by functional collaborators and Process Owners in alignment with Worldwide’s procedures for QMD lifecycle management.

• Manage external distribution of QMDs to support project teams, audits and inspections.

• Collaborate with internal stakeholders to support compliance with Quality Management System (QMS) and QMD lifecycle requirements.

• Format, QCs and publish QMDs and other deliverables under tight timelines with exceptional accuracy.

• Proofreading and editing QMDs with an eye for detail to ensure clarity, accuracy, and adherence to Worldwide standards.

• Correcting errors and identify formatting issues.

What you will bring to the role  

• High level of proficiency with Microsoft applications, including Word, Excel, SharePoint, PowerPoint and Visio.

• High level of proficiency in the English language, including written, oral and reading skills.

• Strong critical thinking skills and exceptional attention to detail.

• Strong teamwork and interpersonal skills, including internal customer service focus.

• Communicates professionally, effectively, clearly and consistently, both verbally and in writing.

• Excellent communication skills, both written and verbal.

• Experience in technical writing or a related field is preferred.

• Familiarity with Visio or similar diagramming tools is a plus.

• Ability to work collaboratively in a team-oriented environment.

Your background

• Bachelor’s degree with concentration in the life sciences or other relevant work experience.

• Minimum of 3 years of experience with document management systems.

• Experience managing GxP procedural documents.

• Understanding of the drug development process preferred. 

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.