Senior Manager, Clinical Process Excellence

AbbVie Inc.; Irvine (CA); On-site; USD 125,000 - 237,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie Inc. seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical processes across domains, enabling operational excellence and regulatory compliance.

You will translate complex challenges into fit-for-purpose solutions and influence cross-functional teams. You will drive end-to-end process design, partner with technology and program leadership on requirements, and set documentation standards to ensure inspection readiness and scalable,

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field.
• Lean Six Sigma certification (Green/Black Belt preferred).
• Minimum 7 years in process design, process engineering, and/or process improvement within a regulated environment.
• Strong knowledge of clinical development operations and regulatory expectations.
• Expert proficiency in process mapping and documentation tools.
• Demonstrated ability to lead multi-stakeholder workshops and drive cross-functional alignment.
• Executive-level communication skills and ability to present to senior leadership.

Responsibilities

• Lead end-to-end process design and optimization across clinical domains or workstreams, managing ambiguity and competing priorities with minimal direction.
• Advise on process strategy, design decisions, and tradeoffs for BPOs and functional leaders.
• Develop and govern process maps, SOP-aligned content, and documentation standards across domains; ensure consistency and scalability across teams.
• Lead current-state assessments and multi-variable analyses to surface issues and prioritize improvements.
• Design and lead complex process design workshops across multi-stakeholder environments; drive decisions and manage escalations.
• Ensure process designs are built for inspection readiness, quality by design, and long-term compliance; mitigate risks.

Skills

Process design

Cross-functional leadership

Analytical skills

Regulatory compliance

Communication

Change management

Education

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

Lean Six Sigma certification (Green/Black Belt preferred)

Tools

Process mapping

Job description

AbbVie Inc. seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical processes across domains, enabling operational excellence and regulatory compliance.

You will translate complex challenges into fit-for-purpose solutions and influence cross-functional teams. You will drive end-to-end process design, partner with technology and program leadership on requirements, and set documentation standards to ensure inspection readiness and scalable,