Associate Director, Quality Systems (Quality Risk Management)

The Associate Director, Quality Systems for Quality Risk Management (QRM) is responsible as the Business Process Owner (BPO) for the development, deployment, maintenance and continuous improvement of the QRM program for AbbVie Research and Development (R&D). The Quality Risk Management position will strategically establish, support, impact, and shape the principle objectives of this organization and to ensure that effective QRM principles and practices are in place across R&D. An effective QRM program is a quality system foundational element 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.

Key Responsibilities Include:

• Collaborate, lead, execute, support, and establish innovative and adaptive QRM principles, strategies and programs supporting the R&D organization.
• Deliver innovative solutions for quality risk management applications that provides adaptive and fit for purpose solutions for the R&D organization.
• Leverage QRM to provide meaningful information and based upon risk management principles drive prioritization and decisions of quality actions.
• Establish comprehensive tools, training, and techniques for QRM applications.
• Establish meaningful metrics for all RDQA that will be reviewed on a regular basis seeking for quality insights, trends and early signals for proactive mitigations.
• Lead and manage broad and cross-functional quality programs and initiatives related to QRM and the AbbVie quality systems.
• Drive transformational change and improvements with a significant impact to the organization, in a highly complex, rapidly evolving regulated environment.

Basic:

• Bachelor's Degree-required in Pharmacy, Engineering, Chemistry, Biology, or Microbiology or relevant course of study.
• 10+ years in pharmaceutical industry; with direct responsibilities in Quality; experience within R&D with significant situational leadership experience.

Preferred Experience:

• Deep QRM expertise and experience regardless of industry (i.e. ICH E6 R2, ICH Q8 etc.)
• Experience implementing QRM programs in past experiences with an understanding of QRM principles and application
• Knowledge of tools and techniques that can be leveraged into actionable activities
• Experience as Lean Six Sigma Blackbelt or other recognized process improvement expertise
• Quality Systems knowledge and related experience

Key Leadership Competencies:

Leadership:

• Lead and mentor the team performing the end to end process, promoting strong collaboration with business partners and stakeholders.
• Lead the development of the global organization and the expansion of the end to end process across the organization.
• Deliver innovative and transformational quality strategies through influence and collaboration with stakeholders at all levels, including senior management.

Business strategy:

• Must be a strategic thinker, yet detail orientated; able to apply strategic thinking skills 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:

• Drives implementation of continuous improvement efforts
• Provide input & guidance to functional SMEs working to improve the process
• Provide 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 to appropriate senior leadership

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.

This is a Lake County based position.