Senior Clinical Process Architect & Strategy Lead

AbbVie Inc.; Lake Forest (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie in Lake Forest, CA, seeks an Associate Director, Clinical Process Engineer to lead and evolve the clinical process engineering capability within Clinical Development Operations. You will define methodology, standards, and governance to enable scalable, inspection-ready processes and enterprise-wide improvements.

You will advise senior leadership on process strategy, oversee end-to-end clinical processes, and build a high-impact team, aligning cross-functional programs with quality and

Qualifications

• Minimum 8 years of 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; demonstrated experience building and scaling process engineering capabilities within a large, regulated organization.
• Proven ability to lead enterprise-level, multi‑stakeholder programs and governance forums with executive presence and strong facilitation skills.

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.

Skills

Process engineering

Stakeholder management

Regulatory compliance

Leadership

Strategic thinking

Executive communication

Program governance

GxP knowledge

Data-driven decision making

Education

Bachelor's degree

Lean Six Sigma Black Belt

Green Belt

Advanced degree preferred

Job description

AbbVie in Lake Forest, CA, seeks an Associate Director, Clinical Process Engineer to lead and evolve the clinical process engineering capability within Clinical Development Operations. You will define methodology, standards, and governance to enable scalable, inspection-ready processes and enterprise-wide improvements.

You will advise senior leadership on process strategy, oversee end-to-end clinical processes, and build a high-impact team, aligning cross-functional programs with quality and