Enterprise Clinical Process Engineer - Strategy & Compliance

AbbVie Inc.; North Chicago (IL); On-site; USD 190,000 - 240,000; 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. This role establishes methodology, standards, and governance infrastructure to enable scalable, inspection-ready processes across the enterprise.

You will operate at the intersection of strategy, compliance, and execution, shaping how the discipline works and building the infrastructure and talent to sustain it long-term.

Qualifications

• 8+ years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).
• Experience leading enterprise-level, multi-stakeholder programs and governance forums with executive presence.

Responsibilities

• Define and own the clinical process engineering methodology, standards, and toolset across Clinical Development Operations; drive adoption and evolution.
• Advise senior and executive leadership on process strategy, capability investments, and cross-functional process architecture.
• Oversee end-to-end clinical processes; ensure coherence, scalability, and inspection readiness across domains and programs.
• Lead enterprise-level current-state assessments and strategic process analyses with capability roadmaps for executives.
• Design and lead enterprise-wide process workshops and governance forums; manage executive stakeholder dynamics and alignment.
• Establish and own process compliance, inspection readiness, and quality-by-design frameworks; partner with quality and regulatory leadership.
• Lead complex cross-enterprise process-to-system programs; ensure quality of inputs feeding technology platforms.
• Own the process performance measurement framework; define KPIs and report to governance bodies.
• Set documentation standards and audit readiness across Clinical Development Operations.

Skills

Process engineering

Regulatory expertise

Executive communication

Stakeholder management

Strategic thinking

Process mapping

Education

Bachelor's degree in engineering or life sciences

Advanced degree preferred

Tools

Lean Six Sigma

Job description

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

You will operate at the intersection of strategy, compliance, and execution, shaping how the discipline works and building the infrastructure and talent to sustain it long-term.