Sr. Manager, Clinical Process Engineer

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 04 direct reports; responsible for performance management development planning and building a high-performing accountable team culture.

Qualifications :

• Bachelors 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time