Senior Clinical Process Engineering Leader (Enterprise)

AbbVie Inc.; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking an Associate Director, Clinical Process Engineer to own the clinical process engineering capability within Clinical Development Operations. This role shapes how the discipline works, building infrastructure and talent for scalable, inspection-ready processes across the enterprise.

You will lead end-to-end governance, drive strategy with executive leadership, and ensure risk-managed, compliant operations across global programs. Strong communication and leadership are essential.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field required.
• 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.
• Exceptional written and verbal communication skills.
• Proven track record of leading high-performing teams in a complex organization.

Responsibilities

• Define and own the clinical process engineering methodology, standards, and toolset; drive adoption.
• Advise senior leadership on process strategy, capability investments, and cross-functional architecture.
• Oversee end-to-end clinical processes for coherence, scalability, and inspection readiness.
• Lead enterprise current-state assessments and translate findings into roadmaps.
• Design and lead enterprise process workshops and governance forums with executives.
• Establish process compliance, inspection readiness, and quality-by-design frameworks; manage risk with quality leadership.
• Lead cross-enterprise process-to-system programs ensuring data integrity for platforms.
• Own the process performance measurement framework; define KPIs and reporting to executives.
• Set documentation standards and governance for audit readiness at function-wide level.
• May manage 0–5 direct reports; lead talent strategy and performance management.

Skills

Process design

Process engineering

Governance design

Executive presence

Stakeholder management

Leadership

Strategic thinking

Communication

Analytical thinking

Education

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

Advanced degree preferred

Lean Six Sigma Black Belt or equivalent

Green Belt required

Job description

AbbVie is seeking an Associate Director, Clinical Process Engineer to own the clinical process engineering capability within Clinical Development Operations. This role shapes how the discipline works, building infrastructure and talent for scalable, inspection-ready processes across the enterprise.

You will lead end-to-end governance, drive strategy with executive leadership, and ensure risk-managed, compliant operations across global programs. Strong communication and leadership are essential.