Senior Clinical Process Architect & Strategy Lead

AbbVie Inc.; Chicago (IL); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. You will establish methodology, standards, and governance to enable scalable, inspection-ready processes across the enterprise.

In this role you will be the enterprise authority on process design, advise senior leadership on strategy and investments, and lead cross-functional programs with executive presence across a global

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field.
• ? Lean Six Sigma Black Belt or equivalent preferred; Green Belt required.
• Minimum 8 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment.
• Deep expertise in clinical development operations and regulatory, inspection, and quality frameworks.
• Expert proficiency in process mapping, methodology development, and governance design.
• Proven ability to lead enterprise-level, multi-stakeholder programs with executive presence.

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.
• 2. 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.
• 3. Oversee the design and governance of end-to-end clinical processes across the enterprise; ensure coherence, scalability, and inspection readiness across domains and programs.
• 4. Lead enterprise-level current-state assessments and strategic process analyses; translate findings into capability recommendations and program-level improvement roadmaps for executive audiences.
• 5. Design and lead high-stakes, enterprise-wide process workshops and governance forums; manage executive-level stakeholder dynamics, resolve competing priorities, and drive strategic alignment.
• 6. 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.
• 7. 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.
• 8. Own the process performance measurement framework for the function; define enterprise KPIs, oversee reporting infrastructure, and present insights to senior leadership and governance bodies.
• 9. 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.
• 10. May manage 0–5 direct reports; responsible for team leadership, talent strategy, performance management, and building a differentiated, high-impact process engineering capability.

Skills

Lean Six Sigma

Executive presence

Facilitation

Leadership

Strategic analysis

Process design

Process mapping

Governance

Education

Bachelor's degree

Advanced degree

Tools

Quality systems

GxP/regulatory knowledge

Process governance tools

Job description

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. You will establish methodology, standards, and governance to enable scalable, inspection-ready processes across the enterprise.

In this role you will be the enterprise authority on process design, advise senior leadership on strategy and investments, and lead cross-functional programs with executive presence across a global