Clinical Process Engineering Leader – Enterprise Impact

AbbVie; California; 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. You will establish methodology, governance, and standards enabling scalable, inspection-ready processes across the enterprise, reporting to executive leadership.

You will shape the discipline, build infrastructure and talent, and lead enterprise-level programs with cross-functional teams, ensuring risk management and regulatory

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field required; advanced degree preferred.
• 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; scalable capabilities in a large, regulated org.
• Proven ability to lead enterprise-level, multi-stakeholder programs and governance forums with executive presence.
• Strategic analytical skills; ability to translate complex environments into executive-ready insights.
• Experience leading large-scale process-to-system transformation programs with risk management and governance.
• Excellent written and verbal communication; experienced presenter to senior leadership.
• Proven track record of leading high-performing teams and enterprise-level judgment.

Responsibilities

• Define and own the clinical process engineering methodology, standards, and toolset; drive adoption and evolution.
• Advise senior leadership on process strategy, capability investments, and cross-functional architecture.
• Oversee end-to-end clinical processes; ensure coherence, scalability, and inspection readiness.
• Lead enterprise current-state assessments and translate findings into capability roadmaps.
• Design and lead enterprise workshops and governance forums with executive stakeholders.
• Establish and own process compliance, inspection readiness, and quality-by-design frameworks.

Skills

Process design

Governance

Executive presence

Strategic thinking

Team leadership

Cross-functional

Education

Bachelor's degree in engineering, life sciences, or business

Lean Six Sigma Black Belt

Green Belt

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, governance, and standards enabling scalable, inspection-ready processes across the enterprise, reporting to executive leadership.

You will shape the discipline, build infrastructure and talent, and lead enterprise-level programs with cross-functional teams, ensuring risk management and regulatory