Director, Quality Systems Excellence

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, RDQA is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

AbbVie’s quality foundation resides in the Quality Policy and Quality System which includes an integrated process model in which AbbVie systematically defines and executes quality objectives, both strategic and applicable regulatory requirements.

Our Core Quality Systems considerations for every process, every solution, every decision incorporates quality, compliance, and operational excellence.

The Director Quality Systems Excellence is responsible for the strategic leadership for the AbbVie R&D Quality System. Primarily responsible for the oversight, execution, deployment, and continuous improvement of the R&D Quality System to ensure appropriate GxP alignment and compliance to evolving regulations.

This role reports directly to the Sr Director, Global Quality Systems.

Major Responsibilities:

 Oversee development, implementation, and continuous improvement of quality system processes through direct and matrix leadership.
 Ensure quality systems are inclusive of current regulations, facilitates compliance, and enables operational excellence.
 Establish, implement, and maintain R&D’s Quality System Ownership (QSO) framework
 Coach, guide, and mentor Quality System Owners (QSOs) in the ownership of their respective quality system processes (CAPA, Risk Management, Change Management, and Quality Event Escalations
 Accountable to drive the quality system processes end to end to ensure sustainability across functions
 Evaluate, interpret, and lead deployment and implementation of the quality system. Initiate continuous improvement activities
 Responsible for the frontline governance to enforce process standards
 Be the single point of contact to address questions & findings, review SOPs and training materials, assess impact – changing regulations, business processes, IT systems, and communication strategy
 Create/maintain process documentation, including ensuring that functional area SOPs work together
 Advocate/Champion the processes, monitor the “health” of the processes through metrics
 Establish strong relations with functional areas
 Maintain deep understanding of the processes, including linkages and interactions of all impacted functional areas and influence both up and down
 Perform all necessary managerial functions and staff programs/projects; operate within budget and headcount.

 Bachelor's degree in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology or Engineering) or equivalent experience of 8 years in related field required
 Strong technical background required. The scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
12 years overall experience including substantial, progressive leadership positions in quality and/or compliance required
 Strategic thinker with strong analytical skills required, including strong perceptual and analytical problem solving skills related to: removal of obstacles, setting of priorities, and ability to diffuse organizational conflicts
 Effective communication skills are required with an ability to work cross-functionally and with a capability to justify quality requirements
 Key leadership competencies required, including cultural awareness, engagement, visibility, relationship building, ability to influence at all levels of the organization, sound judgment and the ability to make difficult decisions under pressure
 The ability to effectively lead complex projects, influence in a matrixed environment, and collaborate across geographically dispersed functional areas
 Experience in two or more of the following areas preferred: Quality Assurance, Compliance, Regulatory, Clinical Operations, Pharmacovigilance, Manufacturing, or Combination products or devices.