Clinical Process Strategy & Governance Lead

BioSpace; Irvine (CA); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. You will establish methodology, standards, and governance to enable scalable, inspection-ready processes across the enterprise.

You will operate at the intersection of strategy, compliance, and execution, shaping how the discipline works and building long-term capability.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or a related field required; advanced degree strongly preferred.
• Lean Six Sigma Black Belt or equivalent preferred; Green Belt required.
• Minimum 8 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).
• Deep expertise in clinical development operations and regulatory, inspection, and quality frameworks.

Responsabilités

• Define and own the clinical process engineering methodology, standards, and toolset across Clinical Development Operations; drive adoption and evolution of the practice.
• Advise senior leadership on process strategy, capability investments, and cross-functional process architecture.
• Oversee end-to-end clinical processes for coherence, scalability, and inspection readiness.
• Lead enterprise-level assessments and translate findings into capability recommendations and roadmaps.
• Design and lead enterprise workshops and governance forums; manage executive stakeholder dynamics and alignment.

Connaissances

Engineering degree

Regulatory knowledge

Stakeholder management

Executive communication

Process mapping

Formation

Bachelors or higher in engineering, life sciences, business

Advanced degree preferred

Description du poste

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. You will establish methodology, standards, and governance to enable scalable, inspection-ready processes across the enterprise.

You will operate at the intersection of strategy, compliance, and execution, shaping how the discipline works and building long-term capability.