Manager, Quality Management Documentation and Quality Management Systems - Europe - Remote

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 

• Identifies and implements improvements within QMS and QMD processes, collaborating on solution-focused activities.

• Develops strategies to engage employees and ensure visibility, access, and clarity of quality procedures.

• Champions change management, particularly related to QMDs, processes, and technology.

• Conducts root cause analysis investigations to address internal and external audit findings related to QMD and QMS.

• Assists in overseeing QMD management processes as a deputy on the QMD/QMS-Governance Committee, ensuring compliance with GxP regulations and defining KQIs and QTLs.

• Collaborates with process owners to design workflows and develop clear, concise QMDs and related GxP documents.

• Conducts initial QMD collaborative reviews and supports formal QMD quality control activities as needed.

• Assists in creating process maps and transforming them into QMDs or supporting materials.

• Provides training on process mapping, workflow design, procedure writing, and content review to process owners, subject matter experts, and collaborative reviewers.

• Supports training of functional training coordinators on QMD/QMS assignments.

• Assists in designing training and communications related to specific training content and supervision.

What you will bring to the role

• Proficient in developing quality management documents, designing process workflows and accompanying job aids in collaboration with subject matter experts

• Experience in project management of complex cross-functional projects, identifying process connections and gaps

• Proficient in developing workflows in electronic Document Management Systems (eDMS) preferred

• Experience developing and tracking key quality metrics to identify areas for improvement

• Demonstrated success managing quality system elements, such as noncompliance management and document change control

• High degree of initiative, decision making skills and responsibility, enabling the incumbent to perform effectively with minimal supervision

• Ability to effectively prioritize and manage multiple projects and tasks and to assist subject matter experts in meeting timelines

• Communicates in an open, clear, complete, timely and consistent manner and express ideas in written and oral context

• Exhibits a flexible, regulatory-focused approach to problem solving and applies risk-based decisions

• Is an adept negotiator, assisting process owners to reach cross-functional consensus on content

Your background 

• Master’s degree in a scientific or allied health filed and 3+ years of Quality Assurance GxP experience OR Bachelor’s degree or equivalent with concentration in nursing, biological, physical, health, pharmacy or other related science and 5+ years of Quality Assurance GxP experience

• Advanced understanding of ICH GCP requirements governing QMS

• Experience with development and implementation of quality systems

• Additional formal training in process mapping and technical writing strongly preferred

• Proven project management experience

• Strong understanding of domestic and international GxP regulatory requirements

• Domestic and international travel required (approximately 15%)

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.