Associate Director, Enterprise Clinical Process Engineering

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Long-term incentive programs

401(k)

Paid time off

Job summary

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

You will lead executive-level initiatives, drive risk-informed investments, and build a durable capability with a focus on quality-by-design and regulatory alignment.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field.
• Lean Six Sigma Black Belt; Green Belt required.
• 8+ years in process design/engineering in regulated environments.
• Expert in clinical development operations and quality frameworks.
• Strong process mapping, governance design, and leadership.

Responsibilities

• Define and own the clinical process engineering methodology and standards.
• Advise senior leadership on process strategy and investments.
• Oversee end-to-end clinical processes for coherence and scalability.
• Lead enterprise-wide process assessments and roadmaps.
• Design governance forums and manage executive stakeholder dynamics.
• Establish compliance, inspection readiness, and quality-by-design frameworks.
• Lead cross-enterprise process-to-system programs and ensure data integrity.
• Own KPI framework, reporting, and presentation to governance bodies.
• Set documentation standards and audit readiness across operations.
• May manage 0–5 direct reports with talent development.

Skills

Process design

Process engineering

Stakeholder management

Governance

Executive presence

Lean Six Sigma Black Belt

Regulatory knowledge

Communication

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

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

You will lead executive-level initiatives, drive risk-informed investments, and build a durable capability with a focus on quality-by-design and regulatory alignment.