Senior Clinical Process Architect & Optimization Lead

AbbVie Inc.; Irvine, Lake Forest (CA, CA); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie Inc. is seeking a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across domains. You will drive cross-functional alignment, translate complex challenges into fit-for-purpose solutions, and influence without authority.

You will shape process engineering across the function, build credibility with stakeholders, and ensure inspection readiness and long-term operational excellence in a regulated environment.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field.
• Lean Six Sigma certification required; Green Belt or Black Belt preferred.
• Minimum 7 years of demonstrated experience in process design, engineering, or improvement in a regulated environment (GxP, clinical development, quality systems).
• Strong knowledge of clinical development operations and regulatory, inspection, and quality expectations.
• Expert proficiency in process mapping and documentation; ability to develop scalable artifacts and standards.
• Proven ability to lead complex multi-stakeholder workshops and drive alignment under ambiguity.
• Executive-level written and verbal communication skills.

Responsibilities

• Lead end-to-end process design and optimization across clinical domains with ambiguity and competing priorities.
• Advise BPOs and functional leaders on process strategy and tradeoffs.
• Develop and govern process maps, SOP-aligned content, and documentation standards.
• Conduct current-state assessments and multi-variable analyses to surface issues and opportunities.
• Design and lead complex process design workshops with multiple stakeholders; drive decisions.
• Ensure designs are inspection-ready, quality by design, and sustainably compliant.
• Lead process-to-system translation with IT, owners, and leadership on requirements and UAT.
• Define and implement process performance frameworks; present KPIs and recommendations.

Skills

Process design

Process engineering

Regulatory compliance

GxP knowledge

Root cause analysis

Cross-functional facilitation

Data-driven decisions

Executive communication

Education

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

Advanced degree preferred

Lean Six Sigma certification

Green Belt or Black Belt preferred

Tools

Process mapping tools

Documentation methods

Job description

AbbVie Inc. is seeking a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across domains. You will drive cross-functional alignment, translate complex challenges into fit-for-purpose solutions, and influence without authority.

You will shape process engineering across the function, build credibility with stakeholders, and ensure inspection readiness and long-term operational excellence in a regulated environment.