Associate Director,Clinical Process Engineer Job Chicago area,Illinois USA,Management

Company Description About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at Follow @abbvie on Linked In,Facebook,Instagram,Xand You Tube.

Job Description Purpose statement

Own and evolve the clinical process engineering capability within Clinical Development Operations, establishing the methodology, standards, and governance infrastructure that enable scalable, inspection-ready, and operationally excellent processes across the enterprise. The Associate Director, Clinical Process Engineer is the functional authority on process design and engineering practice, operating at the intersection of strategy, compliance, and execution. This role shapes how the discipline works, not just what it delivers, and is accountable for building the infrastructure and talent that sustains the capability long-term.

Operates within a multilayered leadership structure and is expected to bring enterprise-level judgment and strong upward credibility.

Major responsibilities

Define and own the clinical process engineering methodology, standards, and toolset used across Clinical Development Operations; drive adoption and continuous evolution of the practice.

Serve as the enterprise subject matter authority on clinical process design, advising senior and executive leadership on process strategy, capability investments, and cross-functional process architecture.

Oversee the design and governance of end-to-end clinical processes across the enterprise; ensure coherence, scalability, and inspection readiness across domains and programs.

Lead enterprise-level current-state assessments and strategic process analyses; translate findings into capability recommendations and program-level improvement roadmaps for executive audiences.

Design and lead high-stakes, enterprise-wide process workshops and governance forums; manage executive-level stakeholder dynamics, resolve competing priorities, and drive strategic alignment.

Establish and own the process compliance, inspection readiness, and quality-by-design frameworks for the function; proactively manage risk and partner with quality and regulatory leadership on emerging expectations.

Lead and govern complex, cross-enterprise process-to-system programs; accountable for the quality and integrity of process design inputs feeding technology platforms and transformation initiatives.

Own the process performance measurement framework for the function; define enterprise KPIs, oversee reporting infrastructure, and present insights to senior leadership and governance bodies.

Set and govern documentation standards, decision record practices, and process governance infrastructure across Clinical Development Operations; responsible for audit readiness at a function-wide level.

May manage 0–5 direct reports; responsible for team leadership, talent strategy, performance management, and building a differentiated, high-impact process engineering capability.

Qualifications

Bachelor's degree in engineering, life sciences, business, or a related field required; advanced degree strongly preferred.
Lean Six Sigma Black Belt or equivalent preferred;
Green Belt required.
Minimum8 years
of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar), with progressively increasing scope and complexity.
Deep expertise…