Duration: 12 months to start

Job Description

• The RDQ Analytics and Center of Excellence (ACE) team is a business operations focused, project-management driven function dedicated to the corporate and Quality goal of strengthening and scaling our organization and capabilities by providing tools, systems, workflows and metrics to drive optimal execution and delivery, portfolio management, and innovative and automative data driven solutions to key initiatives within Research & Development Quality Assurance.
• The Project Coordinator role will contribute to the delivery of operational projects and activities within RDQ aimed at enhancing business processes and systems, in order to drive effectiveness, standardization, harmonization, and improved productivity across the department.
• The Project Coordinator will provide essential administrative support to the project management team within ACE and as appropriate, other RDQ teams such as Compliance and Issue Management, Quality Risk Management and Patient-Centric Ethics, Vendor Quality Management (including GLP, Biomarkers, and Research), Global Clinical Quality, GVP and Real-World Evidence to ensure the smooth execution of project activities.
• This role is ideal for individuals who excel in organizational tasks, have a keen eye for detail, are proficient in data entry and documentation, and have a solid understanding of quality concepts.

• Responsible for participating in discussions with stakeholders to gather and document business requirements. Expected to assist project managers and the ACE team with analyzing, researching, and recommending solutions to business problems related to R&D Quality.
• Analyzes data and processes, supports process mapping in order to identify areas for improvement.
• Provides timely updates to ensure transparency and understanding among groups. Engages with stakeholders in Quality and other Business areas to ensure alignment and maintain project timelines.
• Works with other RDQ teams as well as cross-functional departments and colleagues to ensure consistency, adherence, communication, training, and appropriate application of these projects and change management tools and best practices.
• Responsible for supporting small to large-scale project or process improvement initiatives, including enhancement and complex change management activities focused on operational excellence and organizational maturity.
• Identifies appropriate cross-functional project representatives and timing for engagement.
• Conducts extensive research and investigations around proposed changes in order to be able to understand root causes that will help identify gaps in process, outliers, anomalies, trends, and patterns.

• Handle data entry tasks, update project databases, track and report key metrics.
• Organize project files and maintain documentation in SharePoint, Teams, OneNote and other platforms.
• Assist in scheduling meetings and maintaining project calendars.
• Prepare and distribute agendas and meeting minutes.
• Monitor project timelines and report status updates to the project manager.
• Assist in preparing project reports and presentations using Microsoft Office applications.
• Perform other administrative tasks to support the project team or other RDQ teams.
• Communicate effectively with management and partner across and within various functional departments.
• Familiarity with SDLC, PLM, Lean Six Sigma, and Agile methodologies to support projects of significant scope is a plus.
• Consultative, listening, and analytical skills; able to be forward-thinking and engage in innovative problem solving and solution development.
• Places a high value on developing and cultivating strong working relationships and stakeholder engagement.
• Knowledge of GCP, with some familiarity with GVP, GMP, GDP, and CMC operations.
• Process mapping skills for evaluating processes and identifying improvement opportunities.
• Works independently and collaboratively as part of a larger team, reporting status and elevating issues to manager where appropriate.
• Proficiency in Smartsheet, Sharepoint and Microsoft Office applications (Word, OneNote, Excel, and Visio).

• B.S. in a scientific, clinical-focused, or other quality-related field and 3-5 years of relevant technical work experience or comparable relevant background.
• M.S. in a scientific, clinical-focused, or other quality-related field and 2-3 years of relevant work experience or comparable relevant background.
• Demonstrable experience in the pharmaceutical, biotechnology, or device industry solving business and/or compliance challenges. Familiarity and prior experience with quality concepts.