The Autumn Group

Compensation

Full Description

Possible Titles R&D Quality Principal Business Analyst R&D Quality Project Lead and Principal Analyst General Position Summary The R&D Quality Assurance (RDQA) Analytics and Centers of Excellence (ACE) is responsible for integrating and standardizing operations, processes, information, data, and technology to advance and align the capabilities, competencies, and outputs of R&D Quality (in the areas of GCP, GLP, GVP, Research, and Real World Evidence / Data) with high value goals / strategy and other related Quality organizations by building a robust data rich landscape that empowers teams through a data-driven decision-making culture. This individual will evaluate future projects and initiatives for scoping, feasibility, and manage delivery of vetted and approved projects that improve business processes and systems to drive effectiveness, standardization, harmonization and improved productivity. Key Responsibilities • Responsible for guiding discussions with stakeholders in order to gather and document business needs requirements. Expectation will be to analyze, research, and recommend solutions to business problems in or pertaining to R&D Quality. • Analyzes data and processes, including process mapping in order to identify areas for improvement. • Serves as the key conduit around communications within project teams to foster transparency and understanding between groups. Communicates with wide range of stakeholders in Quality as well as other Business areas to ensure alignment and understanding. • Responsible for providing strategic input, technical and project management oversight to various functions across RDQA using project management standards (PMBOK, Lean Six Sigma). • Works with cross functional departments and colleagues to ensure consistency, adherence, communication, training and appropriate application of these project and change management tools and best practices. • Responsible for the management of small, medium, and large-scale projects or process improvement initiatives. Includes enhancement and complex change management activities focused around 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. General Responsibilities And Required Skills • Ability to influence teams and drive decision-making in a collaborative working environment. • Communicate effectively with stakeholders, management, and LT members. Able to partner across and within various functional departments. Comfortable leading meetings and guiding discussions. • Consultative, listening, and analytical skills; able to be forward-thinking and engage in innovative problem solving and solution development. • Stakeholder Engagement, management and Business Relationship Management best practices. Places a high value on developing and cultivating strong working relationships both internally and externally. • Strong working knowledge of Good Clinical Practices (GCP) with some familiarity of GVP, GMP, GDP and CMC operations. • Demonstrated use of process mapping skills to evaluate health of a process and reveal opportunities for improvement. • Robust change management skills and ability to implement governance methodologies. • Works independently and collaboratively as part of a larger team, reporting status and elevating issues to manager where appropriate. • Demonstrated proficiency using Microsoft Office applications required (including MS Word, OneNote, Excel, Project, Visio, SharePoint). • Experience running projects or working knowledge of key concepts from the following: Software Systems Development Lifecycle (SDLC), Product Lifecycle Management (PLM), Lean Six Sigma (LSS) and Agile (SCRUM/Kanban) methodologies to effectively manage projects/teams of significant scope and complexity. • May serve as Subject Matter Expert (SME) for some projects and initiatives supporting the key areas listed in the position summary, requires understanding of various quality functions such as vendor oversight, inspection readiness, risk management, and other critical to quality areas. Preferred Education And Experience • B.S. in a scientific, clinical focused, or other quality related field and 5-7 years of relevant technical work experience or comparable relevant background. • M.S. in a in a scientific, clinical focused, or other quality related field and 3-5 years of relevant work experience or comparable relevant background. • Demonstrable experience in the pharmaceutical, biotechnology or device industry solving business and/or compliance challenges.