Sr. Manager, Clinical Process Engineer

Posted 2 Days Ago
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North Chicago, IL, USA
Hybrid
125K-237K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Leads the design, optimization, governance, and sustainment of clinical development processes in a regulated environment. Advises functional leaders, develops process documentation and performance frameworks, facilitates complex workshops, translates processes into system requirements, supports UAT and inspection readiness, mitigates compliance risks, and drives cross-functional improvement initiatives. May manage up to four direct reports and operates independently across global, matrixed teams.
Summary Generated by Built In
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

  1. Lead end-to-end process design and optimization across multiple clinical domains or workstreams simultaneously, managing ambiguity and competing priorities with minimal direction.
  2. Serve as a primary process engineering resource for BPOs and functional leaders, advising on process strategy, design decisions, and tradeoffs.
  3. Develop and govern process maps, work instructions, SOP-aligned content, and documentation standards across assigned domains; ensure consistency and scalability across teams.
  4. Lead comprehensive current-state assessments and multi-variable process analyses to surface systemic issues, prioritize improvement opportunities, and recommend enterprise-aligned solutions.
  5. Design and lead complex process design workshops across multi-stakeholder environments, including navigating competing interests, driving to decisions, and managing escalations appropriately.
  6. 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.
  7. Lead process-to-system translation efforts, partnering with technology teams, business system owners, and program leadership on requirements, UAT, and readiness.
  8. Define and implement process performance frameworks; recommend KPIs and instrumentation strategies; present findings and improvement recommendations to functional leadership.
  9. Maintain and continuously improve controlled documentation practices across a domain; contribute to governance standards and documentation policy development.
  10. 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

Skills Required

  • Bachelor's degree in engineering, life sciences, business, or a related field
  • Lean Six Sigma certification
  • Green Belt or Black Belt certification
  • At least 7 years of experience in process design, process engineering, or process improvement within a regulated environment
  • Strong knowledge of clinical development operations and regulatory, inspection, and quality expectations
  • Expert proficiency in process mapping, documentation methods, and related tools
  • Experience leading complex, multi-stakeholder workshops and driving cross-functional alignment
  • Advanced analytical skills, including root cause analysis, risk assessment, and process performance analysis
  • Experience leading process-to-system initiatives, including requirements definition, UAT strategy, and system readiness
  • Executive-level written and verbal communication skills
  • Experience managing multiple high-priority workstreams in a matrixed global environment
  • Advanced degree

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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