Director, Clinical Process Engineering at AbbVie · LumiJobs

Responsibilities

Lead Process Engineering Team and contribute to the design, mapping, and documentation of end-to-end clinical business processes, ensuring alignment with business needs, regulatory requirements, and process excellence standards.
Collaborate with Business Process Owners (BPOs), Process Experts, and cross-functional stakeholders to define future-state processes, clarify decision rights, and ensure clear handoffs and ownership.
Develop and maintain process maps, work instructions, SOP-aligned content, and supporting documentation using appropriate standards and methods (e.g., BPMN/process mapping, Lean/Six Sigma concepts).
Conduct current-state assessment and process analysis (cycle time, handoffs, rework, risk) to identify improvement opportunities and inform fit-for-purpose future-state designs.
Facilitate process design workshops and working sessions with SMEs, system owners, and compliance partners to gather requirements, validate process flows, and confirm controls and roles.
Ensure process designs incorporate compliance, inspection readiness, and quality-by-design principles, including appropriate controls, traceability, and documentation rigor.
Partner with technology and business system owners to translate process designs into system requirements and enablement (e.g., user stories, acceptance criteria, UAT support, and readiness inputs).
Define and recommend process performance measures and instrumentation approaches; partner with BPOs to establish process signals and monitoring where applicable.
Maintain controlled process documentation and decision records, ensuring updates are versioned, communicated, and aligned to governance and audit expectations.
Bachelor’s degree in engineering, life sciences, business, or a related field required; advanced degree preferred.
Lean Six Sigma or similar process methodology certification required.
Minimum 10 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).

Director, Clinical Process Engineering

Responsibilities

Qualification

Required

Preferred

Benefits

Company

AbbVie

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