Director, R&D Quality Analytics Center of Excellence

Role Summary

Director, R&D Quality Analytics Center of Excellence. Leads and oversees large and small ACE initiatives within RDQA and related Vertex Quality organizations to build a data-driven, standardized operations and analytics landscape that supports high-value goals and strategy across the organization.

Responsibilities

• Help define the strategic direction of RDQA and support process development and optimization, technological innovation and continuous improvement within RDQA verticals and extended Quality.
• Recommend, interpret, and execute modifications and activities for the development and advancement of the RDQA processes, analytics, and information framework to enable effective quality oversight, governance, communication and data driven decision making.
• Work with functional area stakeholders to assess and prioritize system and business needs related to technology and process optimization.
• Provide leadership and oversight to the RDQA portfolio of key business initiatives:
  • Provide operational insights that relate to or are impacted by solutions
  • Call out risks and issues early with an appropriate mitigation strategy.
  • Participate in the design and development of metrics, reports, and dashboards to monitor and track progress and data driven insights.
  • Participate in governance committees as they relate to process, data and technical operations
  • Represent RDQA on cross-functional initiatives focused on operational excellence, process optimization data reporting and visualization to ensure consistency and alignment across the organization
• Provide oversight and support during ideation and requirements definition, systems and process design, development, and testing activities to ensure stability, scalability and sustainability of outputs and deliverables.
• Support the Analytics team in providing data translation to teams ensuring quality, business needs and workflows are adequately aligned.
• Remain at the forefront of industry specific processes, regulations, best practices, systems and technologies understanding their applicability and functionality to the business strategy within RDQA and Vertex.
• Supervise and train direct reports providing support and assistance at the appropriate levels to ensure productivity and produce results.
• Evaluate staff performance and ensure optimal training, growth and development to foster a positive and motivated work environment.

Qualifications

• Minimum Qualifications: B.S. in a scientific or allied health field and 10+ years of relevant work experience.
• Strong collaborative leadership, decision-making, negotiation and interpersonal skills.
• Strong problem solving and critical thinking skills, with analytical thinking and data analysis skills to support data translation / data literacy.
• Strong project management skills with the ability to manage projects and initiatives using best practices; lean Six Sigma certification or strong understanding of project management principles.
• Able to manage multiple projects and project teams simultaneously and to communicate, manage and mitigate risk with senior management.
• Able to assess and articulate business justification to projects including ROI and value stream propositions.
• Stakeholder management and governance including representation at Steering Committees.
• Working understanding of BI/visualization tools (e.g., PowerBI, Snowflake) and experience with quality management applications (e.g., Veeva).
• Advanced Microsoft Office suite and Smartsheet skills for dashboard reporting and analytics.
• In-depth knowledge of GxP good practices (e.g., GCP) and applicable regulations guiding drug development life cycle and quality management.

Education

• B.S. in a scientific or allied health field

Skills

• Leadership, collaboration, and stakeholder management
• Analytical thinking and data translation / data literacy
• Project management and process optimization
• Data visualization and BI tools
• Regulatory knowledge (GxP, GCP)

Additional Requirements

• Remote-Eligible designation; potential for remote/hybrid/work-from-office arrangements as per policy