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

Worldwide Clinical Trials Limited; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading global CRO is seeking a Senior Specialist for Quality Management Documentation on a fixed-term basis. This remote role involves ensuring compliance with document standards, managing QMDs, and collaborating with various teams. Ideal candidates will have a life sciences degree and experience in document management, with strong attention to detail and communication skills.

Qualifications

• 3+ years of experience with document management systems.
• Experience managing GxP procedural documents.
• Understanding of the drug development process is advantageous.

Responsibilities

• Perform document control activities for procedural document development.
• Manage external distribution of QMDs for audits and inspections.
• Collaborate with internal stakeholders for QMS and QMD lifecycle compliance.

Skills

Attention to detail

Critical thinking

Teamwork

Communication

Technical writing

Education

Bachelor’s degree in life sciences or related field

Tools

Microsoft Office Suite

SharePoint

Visio

Job description

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

Job Overview

We are seeking a Senior Specialist in Quality Management Documentation to join our team on a fixed-term basis. This role is remote within Europe, with locations including the UK, Poland, Spain, Croatia, and Romania. The position is full-time.

About Us

Worldwide Clinical Trials is a global, midsize CRO committed to innovation and excellence in healthcare. Our mission is to improve lives through passionate and purposeful work. We value diversity, inclusion, and a collaborative environment.

Department Overview

The Quality Assurance department at Worldwide sets high standards for quality, exceeding sponsor and regulatory expectations by empowering staff and fostering a quality-centric culture.

Key Responsibilities

1. Perform document control activities, ensuring compliance with applicable standards for procedural document development.
2. Manage external distribution of QMDs to support project teams, audits, and inspections.
3. Collaborate with internal stakeholders to support QMS and QMD lifecycle compliance.
4. Format, quality check, and publish QMDs and other deliverables accurately under tight deadlines.
5. Proofread and edit QMDs to ensure clarity, accuracy, and adherence to standards.
6. Identify and correct formatting issues and errors.

Qualifications and Skills

1. Proficiency in Microsoft Office Suite and SharePoint.
2. Excellent command of the English language, both written and oral.
3. Strong attention to detail and critical thinking skills.
4. Effective teamwork and communication skills.
5. Experience in technical writing or related fields preferred.
6. Familiarity with Visio or similar tools is a plus.

Minimum Background

1. Bachelor’s degree in life sciences or related field, or equivalent experience.
2. At least 3 years of experience with document management systems.
3. Experience managing GxP procedural documents.
4. Understanding of the drug development process is advantageous.

Additional Information

We are committed to creating an inclusive environment and are proud to be an equal opportunity employer. For more information, visit our careers page or connect with us on LinkedIn.