Director, Clinical Process Engineering
Removed from the employer's board on Nov 6, 2026. First seen by Alion on Nov 6, 2026. AbbVie scores B on the Alion truth index.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Lead the Clinical Process Engineering team while contributing to the design, optimization, and sustainability of clinical business processes to enable operational excellence, compliance, and innovation across Clinical Development Operations. The Director, Clinical Process Engineering partners with business process owners, change, learning, and compliance teams to translate business needs into robust, scalable, and inspection-ready process designs that drive measurable business outcomes and continuous improvement.
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).
Working knowledge of clinical development operations and associated regulatory/inspection expectations (e.g., documentation rigor, traceability, and controls).
Proficiency in process mapping and documentation techniques and tools; ability to develop clear, consumable process artifacts for diverse audiences.
Experience facilitating workshops, eliciting requirements, and aligning stakeholders to achieve timely decisions and high-quality designs.
Strong analytical skills (e.g., root cause analysis, risk assessment, process performance analysis) and structured problem solving.
Experience partnering with technology/system teams on process-to-system translation (requirements, user stories, acceptance criteria, and UAT support).
Strong written and verbal communication skills, including the ability to translate complex process topics into clear guidance and recommendations.
Ability to work effectively in a matrixed, global environment and manage multiple priorities with strong attention to detail and accountability.
Key Stakeholders:
Business Process Owners (BPOs) and Process Experts.
Clinical Development Operations functional leaders and operational teams (process users).
Process Excellence / process architecture partners (process architects/engineers, process governance leads).
Quality, compliance, and inspection readiness partners.
Change Engagement / change management partners.
Learning / training partners.
Business system owners and technology partners supporting the process domain.
Cross-functional SMEs and governance forum participants.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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