What are the responsibilities and job description for the Director of Document Control position at Worldwide Clinical Trials?
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 almost 2,500 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.
What the Director of Document Management does at Worldwide
The Director of Document Management is responsible for the oversight, planning, and execution of Worldwide’s GxP Quality Document Control group. This role is a Champion of the Quality Management System and works across Worldwide to ensure Quality Documents, such as Policies, SOPs, and tool that guide work processes are compliant and disseminated throughout the organization to ensure quality deliverables. This role will think strategically and identify areas to improve the effectiveness and efficiency of Worldwide document management processes and drive to execution. This position reports directly to the Head of QA Internal Compliance Program.
The Director of Document Management oversees quality control of all Worldwide GxP Quality Management Documents to ensure employees have clear, effective and compliant procedures to guide their work. This individual will look for solutions to ensure QMDs are effective and meeting business needs and drive change across the organization to implement solutions. This role serves as a positive ambassador of the QA organization with internal and external customers.
What you will do
- Establish standards for QMD compliance, including format requirements, minimum content, regulatory references. As such, stays updated on regulations and collaborates with cross-functional areas to ensure appropriate standards are incorporated into QMDs.
- Contribute and support the creation of QMDs across the organization. Author, review, approve, and manage Policies, Standard Operating Procedures, and other related GCP/GLP/GVP documents in support of the Quality Manual.
- Serve as a SME for Process Management in support of Worldwide’s Audit & Inspection Program. Contribute as necessary to any CAPA and/or follow up required as a result of audit/inspection.
- Initiate, create and manage communication across the organization to ensure all areas are sufficiently informed of QMD releases, changes and requirements.
- Responsible for supervising the workload and evaluating performance of direct reports through coaching, mentoring and provision of constructive feedback. Conducts employee performance appraisals as per Worldwide processes.
- Organize and lead QMD-Governance Committee in overseeing that QMD management processes are robust, risk based, reflective of GxP regulations, as well as defining Key Quality Indicators (KQIs) and Quality Tolerance Limits (QTLs), reporting monthly to the Quality Management Council.
What you will bring to the role
- Ability to manage GxP procedural documents.
- Understanding of the Drug Development Process.
- Proficiency with Microsoft based applications, including in Excel, Word, SharePoint, and PowerPoint. Experience with Electronic Document Management Systems (e.g., TrackWise is an asset.
- Proficiency in English, including speech, reading, and writing is essential.
Your experience
- Possess broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities.
- Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree.
- Excellent understanding of the Drug and Device Development Process.
- Previous experience in leading Process Management activities in the last 2 years.
- GLP, GLP, GVP, GPP and GMP knowledge an asset.
- Proven experience in developing, managing and complying with annual budgets.
- Ability to speak, read and write English fluently
- S. in a scientific or allied health filed and 7 years of relevant GCP, GLP, GLP, GVP and GPP experience
-Or- - Four-year college curriculum with concentration in nursing, biological, physical, health, pharmacy or other related science and 10 years of relevant GCP, GLP, GVP experience.
- And ≥3-5 years of managerial experience.
- IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, SharePoint, and PowerPoint.
- Domestic and international travel required (approximately 15%).
Why Worldwide
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
