Lead Clinical Process Engineer, Operations Excellence

AbbVie; California; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

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

You will shape process engineering work across Clinical Development Operations, partnering with BPOs, functional leaders, and technology teams to ensure scalable, compliant processes and

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, process engineering, and/or process improvement within a regulated environment.
• Strong knowledge of clinical development operations and associated regulatory, inspection, and quality expectations.
• Expert proficiency in process mapping, documentation methods, and tools; ability to develop scalable process artifacts and standards across teams.
• Proven ability to lead complex, multi-stakeholder workshops and drive cross-functional alignment to decisions under ambiguity.
• Advanced analytical skills (e.g., root cause analysis, multi-variable risk assessment, process performance analysis).
• Demonstrated experience leading process-to-system initiatives, including requirements definition, UAT strategy, and system readiness.
• Executive-level written and verbal communication skills; ability to present complex process topics to senior stakeholders with clarity and confidence.
• Track record of managing multiple high-priority workstreams in a matrixed, global environment with high accountability and independent judgment.

Responsibilities

• Lead end-to-end process design and optimization across multiple clinical domains or workstreams.
• Serve as primary resource for process strategy, design decisions, and tradeoffs for BPOs and functional leaders.
• Develop and govern process maps, SOPs, and documentation standards across domains; ensure consistency and scalability.
• Lead current-state assessments and multi-variable analyses to surface issues and prioritize opportunities.
• Design and lead complex process design workshops with multi-stakeholder environments.
• Ensure process designs are inspection-ready, quality-by-design, and compliant; mitigate risks.
• Lead process-to-system translation with technology teams and program leadership (requirements, UAT, readiness).
• Define and implement process performance frameworks; propose KPIs and instrumentation strategies.
• Maintain and improve controlled documentation practices; contribute to governance and policy development.
• May manage 0–4 direct reports, focusing on performance and development of a high-performing team.

Skills

Cross-functional leadership

Executive-level communication

Analytical skills

Process mapping

Education

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

Lean Six Sigma certification (Green Belt/Black Belt preferred)

Advanced degree preferred

Job description

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

You will shape process engineering work across Clinical Development Operations, partnering with BPOs, functional leaders, and technology teams to ensure scalable, compliant processes and