Lead Clinical Process Engineer - Ops & Compliance

BioSpace; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Benefits package

Long-term incentive programs

Job summary

AbbVie in Irvine seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across multiple domains, enabling regulatory compliance and scalable innovation in Clinical Development Operations.

You will drive cross-functional alignment, translate complex challenges into fit-for-purpose solutions, and build credibility to influence without authority while shaping governance and documentation standards.

Qualifications

• Bachelor's degree in engineering, life sciences, business required; advanced degree preferred.
• 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 (GxP, clinical development, quality systems, or similar).
• Strong knowledge of clinical development operations and associated regulatory, inspection, and quality expectations.
• Expert proficiency in process mapping, documentation methods, and tools; demonstrated 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); ability to translate data into strategic recommendations.
• Demonstrated experience leading process-to-system initiatives, including requirements definition, UAT strategy, and system readiness.
• Executive-level written and verbal communication skills; able 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.
• 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.
• 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.
• Ensure processes are inspection-ready, quality by design, and compliant.
• Lead process-to-system translation with technology teams and program leadership.
• Define and implement process performance frameworks; present findings to leadership.
• Maintain controlled documentation practices and governance standards across domains.
• May manage 0–4 direct reports.

Skills

Lean Six Sigma

Analytical skills

Executive communication

Clinical development operations

Workshops leadership

Process-to-system leadership

Multi-workstream management

Education

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

Advanced degree preferred

Tools

Process mapping

Documentation methods

Job description

AbbVie in Irvine seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across multiple domains, enabling regulatory compliance and scalable innovation in Clinical Development Operations.

You will drive cross-functional alignment, translate complex challenges into fit-for-purpose solutions, and build credibility to influence without authority while shaping governance and documentation standards.