Manager, Quality Systems (Data Analytics)

The Quality Systems (Data Analytics) Manager is responsible for development, deployment, maintenance and continuous improvement of the Quality Management System for AbbVie Research and Development (R&D). The RDQA QSSS Data Analytics position will strategically supports, impacts, and shapes the principle objectives of this organization and to ensure that effective quality systems and services are in place across R&D to allow development of high quality, safe and effective products in compliance with global regulatory requirements and applicable Policies, processes and procedures. These objectives support pharmaceuticals, biologics, combination products and medical devices reporting into the Senior Director, RDQA Quality Systems and Support Services.

Key Responsibilities Include:

• Data Analytics for RDQA:
• Creating and establishing a quality analytics program for R&D Quality Assurance.
• Position will manage data from multiple systems and platforms and merge into useful data that provides early signals for the organization.
• Establish tools and techniques to visualize the data into meaningful information and based upon risk management principles to drive prioritization of quality actions.
• Establish meaningful metrics for the RDQA that will be reviewed on a regular basis seeking for quality insights, trends and early signals.

Key Leadership Competencies:

• Leadership:
  
  • Lead the team performing the end to end process,
  • play a leadership role in the development of the global organization and also lead the expansion of the end to end process across the organization.
  • Influential, transformational and charismatic leadership styles are necessary to work well amongst these differing stakeholders.at all levels within the organization
• Business strategy:
  
  • Must be a Strategic thinker, yet detail orientated; able to think strategically and connect the end to end process to the strategy of the business Work cross-functionally to define strategy for the overall process
  • Align process strategy with organizational goals and performance
  • Set and document process goals and requirements
• Process improvement
  
  • Implement (or support implementation of) continuous improvement efforts
  • Provide input & guidance to functional SMEs working to improve the process
  • Bring expertise and best-practices knowledge to improvement efforts
  • Ensure involvement and support from key process stakeholders
• Process governance
  
  • The RDQA QSSS Data Analytics Position:
    
    • Is the "D" in setting standards and ensuring the process is followed
    • Champions the process to ensure organizational support
    • Manages process-related documentation
    • Escalates issues when agreement across the organization cannot be reached
• Communication
  
  • Communicate locally and globally to ensure information is being delivered to the correct audience
  • Communicate process improvements: Upcoming, in-process, rolling out
  • Provide updates on process performance
• Measure and Analyze
  
  • Measure value provided by process to organization
  • Identify potential areas for targeted improvement
  • Assess & prioritize improvement efforts
  • Track trends and maintain control metrics
• Knowledge: It is critical for Process Owners to have a high degree of process and functional knowledge, A thorough understanding of the end to end process as well as knowledge of the functional organization.

Required Experience:

• Bachelor's Degree-required in Pharmacy, Engineering, Chemistry, Biology, Microbiology, or relevant course of study

Preferred Experience:

• Experience implementing analytics programs in past experiences
• Understanding of mining data and the application of turning data into usable/actionable
• Knowledge of tools and techniques that can be leveraged into actionable activities
• Being able to network map disparate data and systems across an organization
• Knowledge of Risk Management principles to help organization focus on the most impactful activities
• Experience as Lean Six Sigma Blackbelt or other recognized process improvement expertise

This is a Lake County based position.

• Quality Systems knowledge and related experience