R&D Quality Operations and Project Lead

R&D Quality Operations and Project Lead Apply LOCATION Boston, MA Full Remote TYPE Contract SALARY $100 - $103 / hr ID j-11386 POSTED Mar 11, 2026 This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is remote.    Position Summary The R&D Quality Operations and Project Lead will focus on integrating and standardizing operations, processes, information, data, and technology to strengthen R&D Quality capabilities across areas such as GCP, GLP, GVP, research, and real-world evidence/data environments. This role supports operational excellence by helping build a robust, data-driven environment that enables teams to make informed decisions, improve compliance, and enhance productivity. The position partners with cross-functional teams to evaluate business needs, support operational initiatives, and implement scalable solutions that improve processes, systems, and overall organizational effectiveness. The individual will assist with operational standardization, information management, strategic initiatives, and the development of tools and processes that support quality and regulatory compliance objectives. Key Responsibilities Develop and enhance training systems such as role-based curricula, procedural documentation, SOPs, work instructions, and job aids. Support financial management, resource planning, process mapping, and change management initiatives. Create and maintain operational tools including templates, trackers, dashboards, and reporting spreadsheets. Analyze complex business problems and recommend scalable solutions that improve efficiency, sustainability, and productivity. Partner with stakeholders to coordinate implementation of process improvements and operational initiatives. Support the setup, implementation, and maintenance of operational standards and best practices across R&D Quality teams. Facilitate discussions with stakeholders to gather and document business requirements. Conduct research and analysis to recommend solutions for operational and compliance challenges. Analyze processes and datasets to identify inefficiencies, trends, anomalies, and opportunities for improvement. Coordinate communication across cross-functional quality teams to improve transparency and alignment. Collaborate with multiple departments to ensure consistent use of project management, change management, and operational best practices. Perform investigations and root cause analysis to identify gaps and support continuous improvement initiatives. Required Skills and Qualifications Strong understanding of clinical trial methodologies and operations, including Good Clinical Practices (GCP), with familiarity in areas such as GVP, GMP, GDP, or CMC operations. Proficiency with Microsoft Office tools, including Outlook, Excel, OneNote, Project, Visio, SharePoint, and similar platforms. Experience supporting process standardization and information management initiatives. Strong stakeholder management and collaboration skills across multiple departments. Excellent communication, analytical, and problem-solving abilities. Ability to work in complex environments while managing competing priorities. Experience supporting or participating in projects using methodologies such as: SDLC Product Lifecycle Management (PLM) Lean Six Sigma Agile (SCRUM / Kanban) Additional experience with: Vendor management Risk assessments CAPA processes Inspection readiness activities Education and Experience Bachelor’s degree in a scientific, clinical, or quality-related discipline with 5–7 years of relevant experience, OR Master’s degree in a scientific, clinical, or quality-related discipline with 3–5 years of relevant experience. Experience within pharmaceutical, biotechnology, medical device, or other regulated industries supporting quality, compliance, or operational initiatives is preferred.