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Senior Specialist, Quality Management Documentation (Fixed Term) - Europe - Remote

Worldwide Clinical Trials

United Kingdom

Remote

GBP 30,000 - 45,000

Full time

2 days ago
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Job summary

A leading clinical research organization is seeking a Quality Assurance professional to manage document control activities and ensure compliance with high standards. The ideal candidate will have a background in life sciences, strong attention to detail, and proficiency in document management systems. This role offers an opportunity to contribute to improving lives through innovative clinical solutions in a collaborative environment.

Qualifications

  • At least 3 years of experience with document management systems.
  • Experience managing GxP procedural documents.
  • Understanding of the drug development process preferred.

Responsibilities

  • Perform document control activities ensuring compliance with standards.
  • Manage external distribution of QMDs for audits and inspections.
  • Collaborate with stakeholders to support compliance with QMS.

Skills

Attention to detail
Critical thinking
Effective teamwork
Communication skills

Education

Bachelor’s degree in life sciences

Tools

Microsoft Word
Microsoft Excel
SharePoint
PowerPoint
Visio

Job description

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, a global team of over 3,500 experts, bright thinkers, dreamers, and doers, changing the way the world experiences CROs — in the best way.

Our mission is to work with passion and purpose every day to improve lives, and we seek individuals who share this pursuit.

Why Worldwide

We believe everyone plays an important role in making a difference for patients and caregivers. From accessible leadership to supportive teams, we are committed to enabling success for professionals from all backgrounds. We prioritize diversity and inclusion, fostering collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best every day. Join us!

What the Quality Assurance Department does at Worldwide

The QA department sets high standards for quality, exceeding sponsor, participant, and regulatory requirements. Our culture is based on training, energizing, and empowering staff to deliver high-quality products.

What you will do
  1. Perform document control activities, ensuring consistency and compliance with standards for procedural document development in line with Worldwide’s procedures for QMD lifecycle management.
  2. Manage external distribution of QMDs to support project teams, audits, and inspections.
  3. Collaborate with internal stakeholders to support compliance with QMS and QMD lifecycle requirements.
  4. Format, quality check, and publish QMDs and other deliverables under tight deadlines with high accuracy.
  5. Proofread and edit QMDs to ensure clarity, accuracy, and adherence to standards.
  6. Identify and correct errors and formatting issues.
What you will bring to the role
  • Proficiency in Microsoft Word, Excel, SharePoint, PowerPoint, and Visio.
  • Excellent command of the English language, both written and oral.
  • Strong critical thinking and attention to detail.
  • Effective teamwork and interpersonal skills, with a customer service mindset.
  • Professional, clear, and consistent communication skills.
  • Experience in technical writing or related fields 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 in life sciences or relevant experience.
  • At least 3 years of experience with document management systems.
  • Experience managing GxP procedural documents.
  • Understanding of the drug development process is preferred.

We are committed to improving lives through our work. To explore other roles, visit our careers page at Discover a world of difference at Worldwide! For more information, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer dedicated to fostering an inclusive environment that encourages diversity, collaboration, and creativity. We believe that when our employees feel valued and included, they can be more innovative and successful. We are committed to hiring the best talent and providing equal opportunities regardless of race, ethnicity, gender, sexual orientation, age, disability, or other protected classes.

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