Sr. Manager, Clinical Process Engineer

BioSpace; Irvine (CA); Sur place; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Benefits package

Long-term incentive programs

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Lean Six Sigma

Analytical skills

Executive communication

Clinical development operations

Workshops leadership

Process-to-system leadership

Multi-workstream management

Formation

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

Advanced degree preferred

Outils

Process mapping

Documentation methods

Description du poste

Company Description

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.

Job Description

Purpose statement

Lead the design, optimization, and sustainment of clinical business processes across multiple functional domains to enable operational excellence, regulatory compliance, and scalable innovation within Clinical Development Operations. The Senior Manager, Clinical Process Engineer operates with significant independence, driving cross-functional alignment and translating complex, ambiguous business challenges into fit-for-purpose process solutions. This role shapes how process engineering work gets done across the function and builds the credibility and relationships needed to influence without authority.

Major responsibilities

• Lead end-to-end process design and optimization across multiple clinical domains or workstreams simultaneously, managing ambiguity and competing 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.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or a related field 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.

Key stakeholders

• BPOs, Process Experts, and functional leaders.
• Clinical Development Operations senior leadership and operational teams.
• Process Excellence / process architecture and governance leads.
• Quality, compliance, and inspection readiness leadership.
• Change engagement, learning, and training partners.
• Technology and business system leaders.
• Cross-functional governance forums and program leadership teams.

Additional Information

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html