Senior Clinical Process Engineering Leader

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

Job summary

AbbVie Inc. is seeking a Senior Manager, Clinical Process Engineer to lead the design, optimization, and sustainment of clinical business processes across multiple functional domains.

You will drive cross-functional alignment, translate complex challenges into fit-for-purpose process solutions, and influence beyond your authority. You will develop process maps, SOP content, and governance standards, partner with technology teams on requirements and UAT, and define performance metrics.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or a 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; 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, managing ambiguity and priorities with minimal direction.
• Serve as a primary process engineering resource for BPOs and functional leaders, advising on process strategy, design decisions, and tradeoffs.
• Develop and govern process maps, work instructions, SOP-aligned content, and documentation standards across assigned domains; ensure consistency and scalability across teams.
• Lead comprehensive current-state assessments and multi-variable process analyses to surface systemic issues, prioritize improvement opportunities, and recommend enterprise-aligned solutions.
• Design and lead complex process design workshops across multi-stakeholder environments, including navigating competing interests, driving to decisions, and managing escalations appropriately.
• Ensure process designs are built for inspection readiness, quality by design, and long-term operational sustainability; proactively identify and mitigate compliance risk embedded in process.
• Lead process-to-system translation efforts, partnering with technology teams, business system owners, and program leadership on requirements, UAT, and readiness.
• Define and implement process performance frameworks; recommend KPIs and instrumentation strategies; present findings and improvement recommendations to functional leadership.
• Maintain and continuously improve controlled documentation practices across a domain; contribute to governance standards and documentation policy development.
• May manage 0–4 direct reports; responsible for performance management, development planning, and building a high-performing, accountable team culture.

Skills

Process design

Process engineering

Regulated environment

GxP knowledge

Stakeholder leadership

Root cause analysis

System readiness

Executive communication

Education

Bachelor's degree

Advanced degree preferred

Job description

AbbVie Inc. is seeking a Senior Manager, Clinical Process Engineer to lead the design, optimization, and sustainment of clinical business processes across multiple functional domains.

You will drive cross-functional alignment, translate complex challenges into fit-for-purpose process solutions, and influence beyond your authority. You will develop process maps, SOP content, and governance standards, partner with technology teams on requirements and UAT, and define performance metrics.