Job Description
POSITION SUMMARY:
The Quality Analytics & Data (QUAD)team is responsible for integrating and standardizing operations, processes, information, data, and technology to advance and align the capabilities, competencies, and outputs of Quality (in the areas of GMP, GDP, 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 manage deliverables as well as advise and support QUAD in design and implementation of quality reports, dashboards, data analytics, and information management tools / technology to enhance decision making, communication, and oversight. This role will be responsible for collaborating across various sub teams, Quality, and analytical / technical business functions to recommend and implement improvements in order to align quality needs and objectives with strategic corporate goals and initiatives.
KEY RESPONSIBILITIES: - Support activities for the development and advancement of the QUAD analytics and information framework to enable effective quality oversight, governance, communication and data driven decision making.
- Provide design, development oversight to teams in QUAD on technology and key business intelligence initiatives.
- Serves as a business analyst, project/technical lead for process and technology initiatives related to data accessibility, data connectivity and aggregate analytics and reporting.
- Provide data translation support (i.e., translate complex data insights into understandable and actionable information for decision-makers) to teams ensuring quality and business needs and workflows are adequately aligned.
- Monitor and ensure the integrity of key data to create a robust data environment and metrics suite for reporting across the development portfolio.
- Support analytics implementation services (i.e., analytics Center of Excellence) including communication, change management, user documentation, and data literacy.
- Serve as subject matter and data expert for specific cross-departmental initiatives.
- Support execution of broader projects and initiatives to help achieve goals and strategic initiatives as well as meet timelines.
- Remain at the forefront of industry specific systems and technologies understanding their applicability and functionality to the analytics strategy within Quality
- Performs other duties as assigned.
KEY TECHNICAL KNOWLEDGE, SKILLS, AND COMPETENCIES: - Strong data visualization skills and experience with relevant tools including (Power BI, Tableau, Snowflake, R, and Python.
- Advanced Microsoft Office suite (including Teams and SharePoint) and Smartsheet skills.
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking / Data Analysis skills required to make sound decisions.
- Understanding of the principles of GxP good practices (e.g., GCP) and applicable regulations guiding the drug development life cycle.
- Understanding of industry standards for Quality Management Systems and familiarity with technology solutions (e.g., Veeva).
- Effective communication skills to communicate professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.
- Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy/completeness, and quality.
- Strong leadership, decision-making, project management, and negotiation skills.
- Ability to support data translation efforts working will all levels of data end users. Develops job aids to foster data literacy and delivers one on one and small group facilitation as appropriate.
PREFERRED EDUCATION AND EXPERIENCE: - B.S. in a scientific or quantitative field such as Data Analytics or Data Science (or equivalent degree) and 5-7 years of relevant technical work experience or comparable relevant background.
- M.S. in a scientific or quantitative field such as Data Analytics or Data Science (or equivalent degree) 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 through the application of analytic approaches strongly preferred.
Job Tags
Contract work, Work experience placement,