Research Development Quality Assurance ManagerClear Point Consultants • Boston, MA, US
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Research Development Quality Assurance Manager
Clear Point Consultants • Boston, MA, US
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job_description.job_card.job_descriptionProficiency in data visualization and analytics tools (e.g., Power BI, Tableau, Snowflake, R, Python). Advanced skills in Microsoft Office, Teams, SharePoint, and Smartsheet. Strong analytical, critical thinking, and problem-solving abilities. Knowledge of GxP principles (e.g., GCP) and applicable regulatory requirements for drug development. Familiarity with quality management systems and relevant technology solutions (e.g., Veeva). Effective communication skills for delivering clear, concise information to stakeholders at all levels. Ability to work independently, manage priorities, and deliver high-quality results. Leadership, project management, and decision-making skills. Experience supporting data translation and fostering data literacy across teams, including facilitating small-group or one-on-one sessions. B.S. in a scientific or quantitative field (e.g., Data Analytics, Data Science) with 5–7 years of relevant experience, or equivalent background. M.S. in a scientific or quantitative field with 3–5 years of relevant experience, or equivalent background. Experience in the pharmaceutical, biotechnology, or medical device industry applying analytics to business or compliance challenges is highly desirable.
The R&D Quality Analytics and Centers of Excellence (ACE) team focuses on standardizing and integrating operations, processes, data, and technology to strengthen quality functions across research, clinical, and real-world evidence initiatives. The team builds a robust, data-rich environment that supports data-driven decision-making and aligns quality objectives with organizational strategy.
This role manages deliverables and provides guidance to RDQA and ACE teams on designing and implementing quality reports, dashboards, data analytics, and information management tools. The position collaborates across teams to recommend and implement improvements, ensuring quality operations are aligned with strategic objectives.
KEY RESPONSIBILITIES :
- Lead initiatives to develop and enhance the RDQA analytics and information framework for effective quality oversight, governance, and decision-making.
- Guide design and implementation of technology and business intelligence solutions within RDQA.
- Act as a business analyst and project / technical lead for initiatives involving data accessibility, integration, and reporting.
- Translate complex data insights into actionable information for stakeholders, ensuring alignment with quality and business workflows.
- Monitor and maintain the integrity of key data to support robust reporting and metrics across R&D programs.
- Support analytics implementation, including communication, change management, user documentation, and data literacy initiatives.
- Serve as a subject matter and data expert for cross-departmental projects.
- Support execution of strategic initiatives, ensuring deliverables meet timelines and objectives.
- Stay current with industry systems and technologies and assess their applicability to RDQA analytics strategy.
- Perform additional duties as assigned.
KEY TECHNICAL SKILLS AND COMPETENCIES :
PREFERRED EDUCATION AND EXPERIENCE :
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