Project Manager (R&D Quality Operations)
Overview
Our client has a key member of their team resigning this month and needs a consultant to get started quickly as a replacement. This role supports the R&D Quality Assurance Analytics and Centers of Excellence function by driving operational excellence, process standardization, and data-driven decision-making across R&D Quality. The consultant will help evaluate business needs, support strategic initiatives, and lead projects that improve RDQA processes, systems, and information management.
This is a 12-month assignment with a strong likelihood of extension. Fully remote candidates are acceptable, while local candidates who can be onsite in the Boston area 2-3 days/week are highly preferred.
Responsibilities
• Support R&D QA Centers of Excellence operations, including process standardization, information management, and operational alignment with corporate and Quality initiatives.
• Evaluate business needs and lead projects that improve R&D QA processes, systems, and operational effectiveness.
• Analyze workflows and perform process mapping to identify gaps, trends, and opportunities for improvement.
• Develop and enhance training systems, including role-based curricula and procedural documentation (SOPs, work instructions, job aids).
• Create and maintain operational tools such as templates, trackers, financial/resource planning tools, and reporting dashboards.
• Partner with stakeholders to gather business requirements, recommend solutions, and coordinate project execution.
• Facilitate cross-functional collaboration and communication across R&D QA and broader Quality teams.
• Support change management initiatives and adoption of standardized project and process management practices.
• Conduct research and root cause analysis to support process improvements, compliance initiatives, and strategic decision-making.
Qualifications
• BS degree minimum; 5-10 years of biotechnology industry experience required. Advanced degree is preferred.
• Strong understanding of clinical trial operations and Good Clinical Practice, with familiarity in GVP, GMP, GDP, and CMC environments.
• Demonstrated project management experience supporting R&D, QA, process improvement, business analysis, or operational excellence initiatives.
• Proficiency with Microsoft Office tools including Excel, Project, Visio, SharePoint, and Smartsheet.
• Experience working with project or process frameworks such as SDLC, PLM, Lean Six Sigma, or Agile (Scrum/Kanban).
• Strong communication, stakeholder management, and analytical skills with the ability to work across cross-functional teams.
Apply tot his job
Apply To this Job
Our client has a key member of their team resigning this month and needs a consultant to get started quickly as a replacement. This role supports the R&D Quality Assurance Analytics and Centers of Excellence function by driving operational excellence, process standardization, and data-driven decision-making across R&D Quality. The consultant will help evaluate business needs, support strategic initiatives, and lead projects that improve RDQA processes, systems, and information management.
This is a 12-month assignment with a strong likelihood of extension. Fully remote candidates are acceptable, while local candidates who can be onsite in the Boston area 2-3 days/week are highly preferred.
Responsibilities
• Support R&D QA Centers of Excellence operations, including process standardization, information management, and operational alignment with corporate and Quality initiatives.
• Evaluate business needs and lead projects that improve R&D QA processes, systems, and operational effectiveness.
• Analyze workflows and perform process mapping to identify gaps, trends, and opportunities for improvement.
• Develop and enhance training systems, including role-based curricula and procedural documentation (SOPs, work instructions, job aids).
• Create and maintain operational tools such as templates, trackers, financial/resource planning tools, and reporting dashboards.
• Partner with stakeholders to gather business requirements, recommend solutions, and coordinate project execution.
• Facilitate cross-functional collaboration and communication across R&D QA and broader Quality teams.
• Support change management initiatives and adoption of standardized project and process management practices.
• Conduct research and root cause analysis to support process improvements, compliance initiatives, and strategic decision-making.
Qualifications
• BS degree minimum; 5-10 years of biotechnology industry experience required. Advanced degree is preferred.
• Strong understanding of clinical trial operations and Good Clinical Practice, with familiarity in GVP, GMP, GDP, and CMC environments.
• Demonstrated project management experience supporting R&D, QA, process improvement, business analysis, or operational excellence initiatives.
• Proficiency with Microsoft Office tools including Excel, Project, Visio, SharePoint, and Smartsheet.
• Experience working with project or process frameworks such as SDLC, PLM, Lean Six Sigma, or Agile (Scrum/Kanban).
• Strong communication, stakeholder management, and analytical skills with the ability to work across cross-functional teams.
Apply tot his job
Apply To this Job